<http://ask.elibrary.com/images/shim.gif> Gannett News Service <http://ask.elibrary.com/pubminis/Gannett_News_Service.gif> WASHINGTON -- Janet Zuhlke is still struggling with legal whirlpools and bureaucratic roadblocks keeping her from getting help for her 16-year-old daughter, disabled because of childhood vaccines. Zuhlke, of Satellite Beach, appeared before a congressional panel Wednesday to update members on her troubled experience with the National Vaccine Injury Compensation Program.

"That past 10 months have been a continuation of the adversarial process I described last year," Zuhlke told members of the House Government Reform Committee.

Last fall, Zuhlke talked to the same panel and described the devastating reaction her daughter Rachel Anne had to a diphtheria, tetanus and pertussis booster shot administered in 1990 when she was 5 and the frustrating years spent trying to win financial assistance from the vaccine compensation program.

A Justice Department official would not talk about the specifics of Zuhlke's case.

Almost 1,800 families have received more than $1.3 billion in compensation from the program. Since 1988, almost 7,000 petitions for claims have been filed. Almost 3,800 were dismissed, and more than 1,300 cases still are in the pipeline, according to the program's Aug. 9 report.

The average time for a successful case to progress from filing a claim to the award of compensation is seven years, said Ron Homer, a lawyer who specializes in vaccine injury compensation. After nine years of legal wrangling, a special master ruled in July 2001 that Rachel Zuhlke is entitled to compensation. A final decision on the amount of compensation is expected by the end of this month, the 10th anniversary of Zuhlke's claim. She says a vaccine left her daughter mentally retarded, confined to a wheelchair and now suffering from optic nerve degeneration that has caused bouts of blindness.

The vaccine injury compensation program, created by Congress to assist disabled individuals quickly and avoid lengthy litigation, hasn't worked, Zuhlke said. "My experience is not at all consistent with that intention," she said. "As I saw the program, it is highly adversarial and, in my opinion, very unfair."

Zuhlke's complaints were received a sympathetic ear from Rep. Dan Burton, R-Ind., committee chairman, and Rep. Dave Weldon, R-Palm Bay. Burton helped write legislation that created the National Vaccine Injury Compensation Program and is sponsoring a new bill intended to improve the claim process and eliminate protracted challenges from the Justice Department and the Department of Health and Human Services.

"(This program) was intended by Congress to provide compensation quickly and easily to people who have suffered very serious injuries," Burton said. "Unfortunately, that doesn't seem to be happening." Weldon sounded incredulous after listening to Zuhlke, including her heartfelt testimony that an expert witness the Justice Department hired had all but accused her of child abuse for submitting her daughter to an intravenous drug treatment that required a five-day hospital stay.

"That's abusive," Weldon said.

The Space Coast congressman, also a physician, spoke highly of the doctors and medical centers the Zuhlke family used and criticized the Justice Department for challenging their judgment on Rachel Zuhlke' s treatment. Paul Harris, deputy associate attorney general, declined to discuss the specifics of Zuhlke's case but defended the agency's administration of the program.

"We, too, are concerned that there are examples of cases that have taken too long to resolve, that there are individuals who are displeased with the manner in which their case has been processed, and that the program is sometimes perceived as too adversarial," Harris said. " These are the exceptions, not the rule." Victims increasingly view U.S. compensation program as adversarial and tightfisted.

By Myron Levin Times Staff Writer

November 29, 2004

Like good moms everywhere, Janet Zuhlke made sure her kids got their shots.

This proved disastrous for her daughter, Rachel. She was a healthy 5-year-old until a brain injury triggered by a routine vaccination left her mentally retarded, physically handicapped and legally blind.

A single mother raising three daughters in Satellite Beach, Fla., Zuhlke needed help with the enormous costs of Rachel's lifetime care. So she brought a case in a federal tribunal set up to handle vaccine injury claims.

There, opposing lawyers hired expert witnesses to prove that Rachel's injuries weren't vaccine-related. When that failed, they balked at paying for costly medicines her doctors said she badly needed.

The Zuhlkes finally won — but it took more than 10 years.

"I thought it was very cruel," Zuhlke said. "People were very aware of the fact that my family was suffering."

The lawyers who opposed the Zuhlkes were not working for a vaccine company but the Justice Department. Government attorneys fought relentlessly to defeat a mother who thought she was doing the right thing by getting her daughter a government-mandated vaccine.

It wasn't supposed to happen that way in the Vaccine Injury Compensation Program, informally known as the vaccine court. Created by Congress and jointly run by the Department of Health and Human Services, the Justice Department and the U.S. Court of Federal Claims, it was designed to shield vaccine makers from damage awards that were threatening to drive them from the business.

It also was supposed to compensate victims in rare cases of injury under a flexible, no-fault system that would avoid the rancor and delay of traditional litigation. Claims were to be handled "quickly, easily and with certainty and generosity," said a House report accompanying the legislation in 1986.

Instead, say advocates for families with injury claims, federal officials often fight them with such zeal that many who deserve help are denied it, and even successful cases get bogged down for years.

The program "was supposed to be non-adversarial and it's become very adversarial," said Rep. Dan Burton (R-Ind.), whose House Subcommittee on Human Rights and Wellness has held hearings on the matter. Many have "had legitimate claims and they went on for eight, nine, 10 years."

Vaccine compensation officials refused to be interviewed, but in written statements they said the program had "an excellent record of promptly and appropriately compensating" valid claims.

Over the years, about $1.5 billion has been paid out in compensation and legal fees for more than 1,800 families, most of which would have had little chance of winning a civil trial, the officials said. They insisted that the vaccine court was less adversarial than civil courts, but said they were obliged to fight claims that weren't based on good science.

This was "never intended to serve as compensation source for … conditions that are not vaccine-related," said Joyce Somsak, the program's acting director.

But in trying to weed out undeserving claims, critics say, the government has insisted on a level of proof of injury that is almost impossible to meet.

And a Times analysis of claims data shows that the court has become more unyielding over time: Officials are much less likely than in earlier years to concede that a vaccine was responsible for an injury or death. The percentage of people getting awards also has declined.

Even when families do win compensation, officials have sometimes battled them over just a few dollars.

In one case, government representatives argued that $150 a year was too much to spend on wheelchair maintenance. They have haggled over how much to allow for replacement shoes and braces for people with polio. Another time, they recommended rubber sheets for the bed of an incontinent person because they were cheaper, although less comfortable, than disposables costing $135 a year.

"We never anticipated the extent [they] would go to deny these kids compensation," said Barbara Loe Fisher of the National Vaccine Information Center, who lobbied for the bill that created the program.

Viewed another way, by being tightfisted, officials have been good stewards of the vaccine injury trust fund, the self-insurance pool that pays awards to the injured. In fact, the fund — fed by a surcharge of 75 cents per vaccine dose — has ballooned to more than $2 billion, while earning about as much in annual interest as it pays in awards.

But the fund was not meant to be a moneymaker. The idea was that it was better to "err on the side of compensating the victim," said Rep. Henry Waxman (D-Los Angeles), sponsor of the legislation.

Roots of the Program

Along with clean water and sanitation, mass immunization ranks among the great milestones in public health. Among its glittering achievements: Measles cases in the U.S. dropped from about half a million in 1960 to 42 last year, according to the Centers for Disease Control and Prevention, or CDC.

But although millions benefit, even the safest vaccines aren't safe for everyone.

Because of genetic differences, some people are harmed by vaccines "that almost everybody else responds to just fine," said Dr. Robert W. Block, former chairman of a federal advisory panel on childhood vaccines.

And some have paid a terrible price. For example, until 2000, when the U.S. switched from the oral live polio vaccine to inactivated polio shots, the vaccine itself caused a few polio cases each year.

Gordon Pierson, a 12-year-old in Jackson, Tenn., contracted polio as an infant this way and is paralyzed and unable to speak.

"We were doing what we thought was best for our son, and the exact opposite happened," said his father, Randy Pierson. "We were just heartbroken, and we are every day."

Fear of legal fallout inspired the National Vaccine Injury Compensation Act. At the time, vaccine makers were facing a surge in claims, mainly from adverse reactions to the diphtheria-pertussis-tetanus, or DPT, vaccine. An exodus from the market and shortages seemed possible. In response, Congress decreed that instead of suing vaccine makers, people would first have to seek compensation from the new vaccine court.

Health and Human Services officials would administer the trust fund and screen petitions, deciding whether to concede or oppose each claim. Justice Department lawyers would appear in court on their behalf.

Petitioners could not seek awards for punitive damages or losses to family members as they could in civil court. But they were to benefit from greater speed and flexibility, and a lower burden of proof. Moreover, the program typically would pay petitioners' legal costs once the case was over, win or lose.

However, what was meant to be a win-win proposition instead has been mostly "a stupendous success in protecting the industry," said George Washington University law professor Peter H. Meyers, who directs a group of law students who represent petitioners. As for helping victims, he said, the record is "much more spotty."

Some see this as a natural result of federal health officials' fierce devotion to the immunization program — and their fear that if enough injuries were acknowledged, people would be afraid to get their shots.

Universal immunization is a fundamental mission of Health and Human Services. One of its branches, the Food and Drug Administration, licenses vaccines, and another, the CDC, promotes their use with such slogans as "Vaccination: An Act of Love."

From the start, agency officials worried that the program might create an exaggerated public impression of the risks of vaccines. At a congressional hearing before passage of the bill, Assistant Secretary for Health Edward N. Brandt Jr. warned that despite the program's laudable goal, it could "provide a significant disincentive to childhood vaccination programs."

Burden of Proof Shifts

In 1995, the government changed the rules of the vaccine court in a way that made cases more contentious, protracted and harder for petitioners to win.

Officials amended the vaccine injury table, a set of guidelines that had tilted many cases in petitioners' favor. According to the table, if certain symptoms appeared within a specified time after a shot, the vaccine was deemed the culprit unless the government could prove another cause. Many "table injuries" were simply conceded by the government, leaving only the amount of compensation to be determined.

A few amendments changed all that. In one major shift, "seizure disorder" was scratched from the table as a telltale sign of injury from a DPT shot. And a new, more restrictive definition of encephalopathy — or brain dysfunction — meant that many conditions that had been table injuries suddenly were not.

Somsak said the table was changed for one reason only: to better "conform with the scientific evidence."

But the upshot was that in many cases the burden shifted from the government to prove the shot didn't cause injury to the petitioner to show that it did. Because it's usually hard to prove with certainty that a vaccine caused harm, the effect of the change was profound.

The Times analyzed a vaccine court database of 10,741 claims filed over 16 years. The analysis showed that in the three years before the changes, the government conceded one-third of all claims. Of cases filed in that period, compensation was awarded in just over half.

But since the changes took effect March 10, 1995, the government has conceded just one claim in seven. About 35% of petitioners have received compensation.

And cases dragging beyond five years have become increasingly common.

Even the court's top judicial officer, Chief Special Master Gary J. Golkiewicz, has lamented the drift toward "full-blown litigation."

"Clearly," he said in one of his rulings, "that is not what Congress intended when it designed the program as an alternative to tort litigation."

Clifford J. Shoemaker, a lawyer for petitioners, said if the government softened its stance, the worst that would happen is that a "family that needs some money to deal with their profoundly injured child is going to get it."

"Is that such a terrible thing?" he asked.

Some observers have warned that the government's uncompromising attitude could backfire.

Although the law directs all claims to vaccine court, it allows those who disagree with a ruling — or have waited more than 240 days — to sue vaccine makers in civil court. So far, few have.

But by their tough stance, officials may be inviting more civil suits, Rep. Waxman said. "The whole idea of the compensation system is to be generous so they [petitioners] won't want to go to court."

Lost on a Technicality

Vaccine court officials were none too generous with Veronica Spohn.

Her parents claimed that a DPT shot caused their infant daughter to suffer brain damage. But they lost on a technicality: Their petition was filed a few hours late.

Although the vaccine compensation program was billed as more flexible, its three-year statute of limitations is draconian compared with rules of civil courts in all 50 states, which place no deadlines on the filing of injury claims for minors.

In the Spohn case, the doctor's records were a mess, alternately giving July 17 and July 19, 1992, as the date of the fateful shot. The family's lawyer filed the petition July 18, 1995, thinking he had made the deadline with a day to spare. In fact, he was a day late.

Seizing on the error, the Justice Department moved for dismissal. Special Master Elizabeth Wright concurred, citing the Spohns' "failure to use due diligence in pursuing the claim."

It was "very much an injustice," said Veronica's mother, Karen Spohn, a nurse in Butler, Pa. "I had a normal child, and all of a sudden in one day, within hours of the vaccine … she became a child with a disability" who is "going to need assistance for the rest of her life."

"They didn't rule that she didn't have damage. All they did was say, you filed 12 hours too late — too bad on you."

Spohn said she was too heartsick at that point to look into filing a civil lawsuit.

"Emotionally I couldn't deal with" continuing the fight, said Spohn, who preferred to "accept what you're dealt with and go through life."

Lengthy Legal Battle

In the case of Dustin Barton, the government fought so long that the Albuquerque boy did not live to see the resolution of his claim.

As an infant, he had suffered seizures and brain damage after a DPT shot. But Dustin had a congenital neurological condition, known as periventricular leukomalacia, that the government blamed for his injuries.

His mother, Lori Barton, filed the claim in November 1991. The case dragged on for years. Barton told friends and family that she suspected the government was waiting for Dustin to die — noting that it would be cheaper for the program to pay the death benefit of $250,000 than to buy an annuity to cover lifetime care.

Dustin eventually did die of a seizure, nearly six years into the case, but the government continued to fight. Finally in May 2000, 8 1/2 years after the petition was filed, the family won a ruling that Dustin's injuries were vaccine-related.

Not ready to give up, Justice Department lawyers considered an appeal. Then they offered a deal: They would drop the challenge if the Bartons agreed the decision would remain unpublished. This meant it would not be sent to legal databases, such as Westlaw, where attorneys for other petitioners could see it.

Lori Barton, who has since died, described her reaction at a congressional hearing in December 2001: "To me, it was extortion." But Barton, who then was seriously ill and had borrowed thousands of dollars to pay expert witnesses, took the deal.

In a statement to The Times, the Justice Department said it had made similar deals "on very rare occasions." It happens when the government "disagrees with a decision but believes that settlement is fair and in both parties' interests."

Family Finances Ruined

Rachel Zuhlke's claim was filed in September 1992. The government blamed her brain injuries on complications from a strep infection she had about the same time she got her DPT shot.

Janet Zuhlke said Rachel's illness contributed to the breakup of her marriage. She also lost her job as a dental assistant because of frequent absences to deal with Rachel's medical emergencies. Even with health insurance, the family's finances were wrecked.

"We had a lot of hot dogs," Zuhlke said. "We had two other children that went without many, many, many things … because I couldn't afford them."

Her case moved at a crawl, getting repeatedly reassigned to different special masters, and from one Justice Department lawyer to another, who repeatedly got extensions to complete filings in the case.

Nearly eight years into the case, Golkiewicz, the chief special master, brought in a mediator for settlement talks. Zuhlke recalled her despair — and the special master's shock — when the Justice Department refused to make a settlement offer. "You should have seen Golkiewicz's face fall on the table," she said.

Golkiewicz said recently that he was disappointed that the case didn't settle, but that didn't mean "that one side or the other was at fault."

Still, he said, the case took far too long, and the Zuhlkes "had every reason to feel frustrated."

As it turned out, the government lost its all-or-nothing gamble. In July 2001, Special Master George Hastings ruled that Rachel was entitled to compensation. Fifteen months later, he granted a multimillion-dollar award, including $925,000 for her pain and suffering, future lost earnings and past medical bills, and at least $90,000 a year for living and healthcare costs.

Although relieved that the case is finally over, Zuhlke still struggles with grief over what happened to her child, now a young woman. Rachel's life, she said, "is so different from what it should be at 20."

And she still finds it "unfathomable" that the government fought her claim for so long, Zuhlke said. "My little girl hadn't done anything wrong."

http://www.smmirror.com/MainPages/DisplayArchiveArticle.asp?eid=2423 Government Of, By and For The Pharmaceutical Industry Dan Hamburg, Mirror contributing writer Hidden in the folds of the thickly pork-laden Department of Defense Appropriations bill that slid through Congress just before Christmas and was signed into law a day before New Year’s was a big slab of holiday cheer for the pharmaceutical industry. There were no press releases from congressional offices and no mention in the news – maybe no one wanted to take credit for this latest assault on the 14th amendment. The so-called “Frist provision” – named after the ethically-challenged physician-turned-politician Bill Frist – will immunize Big Pharma from responsibility for vaccine-related injuries. The main rationale for this latest gift to industry at the expense of the public is – you guessed it! – the War on Terror.

Our representatives in Congress pled that corporations like Merck, GlaxoSmithKline, Wyeth, and Eli Lilly might just have to close up shop if they were forced to take responsibility for injuries caused by their products. These companies hardly need the help. Pharmaceuticals, despite their whining about risk, are some of the most profitable businesses in the country with the median profit margin of the top 10 companies more than five times that of all other industries on the Fortune 500 list.

Vaccine-induced injury has been around for as long as vaccines. The most famous case is the 1955 “Cutter incident” in which massive scientific, regulatory and industrial failure led to hundreds of thousands of people being injected with live polio virus. 70,000 people contracted the disease within days of being vaccinated, 200 were permanently paralyzed and 10 died. Two vaccines came into question in the 1990s: measles-mumps-rubella (MMR) and hepatitis B. According to research reported in 1998 by British physician Andrew Wakefield and since confirmed by others, the MMR vaccine may cause gastrointestinal problems that can lead to autism. In 1998, France became the first country to stop requiring hepatitis B vaccination for school children, following reports that French children were developing chronic arthritis and symptoms resembling multiple sclerosis following administration of the vaccine.

By 1999, the American Academy of Pediatrics (AAP) and the Centers for Disease Control (CDC) had suspended the hep B vaccine for low-risk newborns. These cases pale in significance compared to the mercury-based vaccine preservative thimerosal. Lilly introduced thimerosal in the 1930s after testing it on a group of patients already suffering from meningococcal meningitis. Doctors injected 22 patients with high levels of thimerosal. Most died within days, from meningitis. Thus, no adverse thimerosal effects were observed. By the 1990s, American children were routinely receiving vaccinations exposing them to up to 87 times the EPA safety limit for adult mercury exposure. Government agencies and the medical establishment argue that there’s no proven connection between high levels of exposure to the mercury in thimerosal and a sixty-fold spike in cases of childhood autism. Others disagree.

In metropolitan Chicago, Homefirst Health Services serves several thousand children whose families have taken advantage of the religious exemption in Illinois state immunization mandates. According to Dr. Mayer Eisenstein, Homefirst’s medical director, of the 35,000 children served by Homefirst over the past thirty years not a single case of autism has been noted among unvaccinated children. Statistically, there should have been over 200 cases of full-blown autism. Similar results have been noted among the Amish in Pennsylvania. No vaccinations, no autism.

American politics is a pay-to-play system. Big Pharma pays big time. Tens of millions of dollars are given to politicians like Senator Frist each and every election cycle to insure that corporate interests trump the rights of mere mortals, including vaccine-injured children and families. The parents of autistic children, who face costs of $3 to $5 million over their child’s lifetime, reasonably seek out the courts as recourse. However, in order for a “vaccine-adverse event” to be compensated in the federally-established Vaccine Court, it must be listed on the federally-established Vaccine Injury Table. Autism is not listed. This is because the Institute of Medicine (IOM) has “failed to find evidence tha thimerosal in vaccines is a causal factor in autism.” The IOM maintains that while such a link is “plausible,” the evidence is insufficient. Recently, the CDC tacked in a different direction, with director Julie Gerberding calling for new studies of the link.

But this begs a prickly and potentially very expensive question: Why have the Centers allowed a huge increase in the exposure of American children to thimerosal without first guaranteeing its safety? After all, mercury has long been known to be a neurotoxin and one of the most dangerous substances on the planet. With the president signing the Frist provision into law, the pharmaceutical industry has secured immunity from legal liability for vaccines and drugs administered to fight “epidemics, pandemics, and bioterror agents.” While the presumption is that this law will be applied prospectively, in treating an avian flu outbreak for example, parents of autistic children are justifiably concerned that it will be applied in a blanket fashion. In other words, total immunity from allegations of harm related to vaccines: past, present, and future. Injured persons would be forced to prove “willful intent to harm” – an extraordinarily high standard – in order to be eligible for compensation. And – surprise! – the new law provides no funds for compensation. We are well down the road of sacrificing our once great country to a flaccid and corrupt government in bed with profit-obsessed, amoral corporations. When will the American people finally say “Enough! We demand our country back!” Dan Hamburg is a former member of Congress. He is currently executive director of Voice of the Environment, a Marin-based nonprofit.

Washington, D.C. - A bipartisan group of lawmakers led by Government Reform Committee Chairman Dan Burton (R-IN) and Ranking Member Henry Waxman (D-CA) today introduced legislation to make the Vaccine Injury Compensation Program more generous and compassionate.

During two days of hearings before the Government Reform Committee, families of injured children complained about long delays, overly adversarial tactics employed by government lawyers, and other difficulties with the program. The legislation introduced today would:

Increase the compensation for vaccine-related deaths to $300,000; Make the compensation for lost earnings more generous; Allow compensation for the costs of family counseling and creating a guardianship; Allow for the payment of interim attorneys fees and costs while a case is under review; Extend the statute of limitations for filing a petition to six years; and Establish a two-year window for families to file a petition if they were previously excluded from the program by the existing two-year statute of limitations.

"Vaccine-related injuries are devastating for families that have to deal with them," said Burton. "Congress intended this program to be swift, compassionate and generous. However, too many times, these families are confronted by bureaucratic indifference, long delays and overly adversarial tactics. We heard testimony from parents who fought for ten years to win compensation for their children. That's not acceptable. This bill won't fix every problem that people have experienced, but it's a good first step. We have bipartisan support for this bill, and I hope we can get it signed into law this year. I want to thank Congressmen Waxman, Congressman Weldon, and all of the other cosponsors who helped put this bill together." "The Vaccine Injury Compensation Program has been largely successful in stabilizing the vaccine industry; in maintaining public confidence in immunizations; and in compensating people who have been injured by vaccines. However, the system is not perfect. This legislation would help to improve the program and help to make sure that it is as generous and easy as it can be," said Waxman. Immunizations are considered the most important public health achievement of the 20th Century. Because of immunizations, children are no longer disabled by polio, suffer brain damage from measles, or die from smallpox. However, immunizations are not risk-free. In rare cases, they can cause serious injuries.

Congress created the Vaccine Injury Compensation Program in 1986 to compensate families quickly and generously when vaccine injuries occur. At the time, vaccine manufacturers were facing numerous vaccine injury lawsuits and were threatening to leave the market. Creation of the VICP helped keep manufacturers in the market and stabilize vaccine supply. Under the program, vaccine makers are partially shielded from liability for vaccine-related injuries. An excise tax is charged with each dose of vaccine. The proceeds go into a Federal fund used to compensate victims.

The legislation expands on a set of reforms proposed by the Advisory Commission on Childhood Vaccines in 1999. It also addresses problems identified by parents of injured children who testified at two Government Reform Committee hearings last fall. Galveston Fed. Judge Rules Parents Cannot File Suit Against Vax Manufacturers Without First Bringing Child's Claim To Vaccine Court

A federal judge in Galveston, Texas has ruled against the parental claims of a vaccine-injured child, dismissing those claims filed in federal district court. The claim was brought on behalf of the parents for "loss of consortium" due to an injury, specifically, autism, caused by vaccines. The parents' derivative claim for loss of consortium is based on their inability to enjoy the relationship they expected to have with their child. Judge Samuel B. Kent explains in his ruling: "Simply put, individuals who qualify as Program claimants must file petitions in the Vaccine Court in order to pursue any vaccine-related claims at all." (cite) The message that Judge Kent is sending is clear: if parents hope to bring a claim that is based on an injury caused by a vaccine, they must bring a claim for their child in the Vaccine Court as directed by federal statute within the time period defined by that statute. Parents must be vigilant in pursuing their claims, and bring those claims on behalf of their children to preserve any related claims they may have. The National Vaccine Injury Compensation Program (NVICP) was established by Congress to compensate those persons who may be injured by routine vaccinations. It requires any claim for compensation relating to a vaccine covered by the NVICP to be filed in the Program. The NVICP created the Vaccine Program Courts in Washington, D.C., which specialize in vaccine injuries and, by law, are required to be the "first line" in determining whether a vaccine-related claim is valid. Vaccine-related claims may be brought in civil court after Program claims are decided, but only if a claim is first brought in the Vaccine Program Court within 36 months of the onset of the first symptoms of injury, or, in death cases, within 24 months from the date of death or 48 months of the date of injury, whichever comes first. "Families should be aware of the NVICP's time limitations, and make sure they consult with an attorney in time to preserve their claims," advises Jeffrey Thompson, lead attorney with The Vaccine Injury Alliance. According to Thompson, "Attorneys who specialize in vaccine injury are available to make sure that claims are brought in the proper court at the proper time, but parents must seek out an attorney as soon as they suspect a vaccine injury has occurred." For more information on the Vaccine Injury Alliance, the NVICP, and to view a copy of Judge Kent's order, please visit the VIA website at www.vaccineinjury.org or call 1-888-709-6674.

Mercury in vaccines leads to wave of suits Stephen Van Drake http://southflorida.bizjournals.com/southflorida/ stories/2002/06/17/story4.html When Alexander Stewart of Aventura says a new word, his family becomes elated, the boy's mother Linda said. Two years ago, Alex, now 8, stopped speaking, lost his appetite and emotionally withdrew from his parents, Linda and Dennis, and older brother, David, 10. Doctors broke the bad news that Alex was autistic. Even worse was the fear that childhood vaccinations may have caused this tragedy. At birth and for the first three years of his life, Alex was normal in every way, Linda Stewart said. "His speech was perfect, and he used to speak French, too, but that's gone now." Like millions of infants, Alex received vaccinations from vials containing the preservative Thimerosal, used since the 1930s and discontinued in the United States in October. The youngster mastered all developmental milestones by age 3. Then, over the following three years, his speech, emotional state and appetite gradually eroded, his mother said. The mystery behind Alex's slide into autism may ride on a tsunami of lawsuits that may soon wash against 10 of the world's largest drug companies and others in the distribution chain of Thimerosal, which plaintiffs say has more than the trace amounts of mercury allowed by federal law. Hundreds of children and their parents in scores of lawsuits filed in South Florida and elsewhere claim Thimerosal's toxic mercury caused autism or similar symptoms. Lawyers say the cases will soon rival asbestos and tobacco suits in prominence before the public. Drug giants deny culpability. They contend there's no reliable scientific data linking Thimerosal to autism or any adverse reactions. Autism is a developmental disorder of the brain affecting social interaction and communication skills. The Thimerosal-autism debate takes center stage July 16 in Cambridge, Mass., as the U.S. National Academy of Sciences Institute of Medicine meets publicly. The stakes are high. Plaintiffs' lawyers say the victims and the damages number in the millions of kids and billions of dollars. Perfect litigation storm? On May 31 in Miami-Dade Circuit Court, the Stewarts sued major pharmaceutical companies, Florida Thimerosal-vaccine distributors and the Miami physician who vaccinated Alex, said their Miami lawyer James L. Ferraro. Ferraro said his firm has filed four such suits in Florida, including one each in Broward and Palm Beach circuit courts. "I wouldn't be surprised that there are tens of thousands of cases out there," he said. The torrent of suits against drug titans promises litigation equal to the assault against Big Tobacco, said Miami mass tort lawyer Roberto Villasante of Robles Law Center. In September, Villasante filed the first Florida Thimerosal suit in Miami-Dade Circuit Court for 5-year-old Steven Demos and his parents, Nick and Linda. Court documents show Steven's scenario closely resembles Alex's. Villasante said he studied Thimerosal for a year before filing this suit. "I met with scientists and doctors all over the country, many national experts, and I'm absolutely certain the science is there that supports our theory of mechanism of injury," he said. Villasante's legal theories include negligence, failure to warn and failure to test Thimerosal, making and selling an inherently dangerous drug (strict liability), civil battery, breach of warranties and violation of Florida's Deceptive Trade Practice Act. He's also the only lawyer demanding that drug companies withdraw and destroy stockpiles of vaccines with Thimerosal made and distributed before October. Villasante said he has filed Thimerosal actions in New York and North Carolina and will file 20 more Thimerosal cases in 15 states within three weeks. The Robles firm leads a national coalition of 25 trial lawyers in 15 states sharing resources that is poised to launch a second wave of lawsuits against pharmaceutical companies. Waters & Kraus of Dallas spearheads a second group of 17 firms, including Ferraro's. Waters filed the first Thimerosal suit, said Tanja K. Martini, a Waters associate. "We have already filed 60 such cases in federal and state courts," she said. Forty more will be filed soon by members of the Waters consortium, Martini said. Waters lawyers will try the first Thimerosal case in February in Texas. The litigation continues to gain momentum. This week, Villasante requested the presiding judge in the Demos case to certify as a class all alleged Thimerosal victims in the nation to force pharmaceutical companies to fund research to medically monitor Thimerosal-affected children. Villasante said disorders from Thimerosal emerge months or years after vaccinations. "I want the drug companies to help monitor and, where possible, identify early symptoms so children and parents can be helped." The case for causation Villasante wrote in the Demos complaint, "In 1982, an expert FDA panel concluded Thimerosal was unsafe and should be removed from all over-the-counter products." Experts agree that if ingested in more than trace amounts, mercury poses health risks. In June 1999, the FDA announced that infants receiving Thimerosal-laced vaccines at several visits may be exposed to more mercury than recommended by federal safety guidelines for total exposure to mercury, Martini said. She also noted that in July 1999, the American Academy of Pediatrics issued a warning that Thimerosal-containing vaccines could be hazardous to infants' health. Last year, the Institute of Medicine published a book, "Immunization Safety Review." It discussed the "plausibility of a causal relationship between vaccines and the neuro-developmental disorder of autism," according to Martini. Ferraro associate L.H. Steven Savola said one overriding factor shines through: statistics. In his March complaint filed in Broward Circuit Court for Mohamed and Juliet Edoo, parents of Justin, Savola wrote that after a typical immunization schedule during the first 18 months of life, American infants were exposed to 237.5 micrograms of mercury from Thimerosal in vaccine products. This exposure exceeds federal guidelines "by a factor of 30-plus times the permissible limit," he stated. Pharmaceuticals' defense Pharmaceutical industry representatives say Thimerosal simply killed bacteria and fungi in multivaccination vials. And it worked well, they said. Doctors could draw up to 10 inoculations from each vile containing Thimerosal. This saved everyone money, according to court documents. Drug companies concurrently made and sold single vaccine vials without Thimerosal. Indianapolis-based Eli Lilly (NYSE: LLY) patented Thimerosal in the 1930s and licensed it to GDL International, Dow Chemical (NYSE: DOW), Sigma-Aldrich (Nasdaq: SIAL), American International Chemical and Spectrum Laboratory Products, co-defendants in these suits. "Eli Lilly knew from the 1930s of the toxic effects of Thimerosal but didn't warn anyone," Martini said. "Instead, it said the drug only contained trace amounts of mercury and said it was non-toxic." Eli Lilly disagreed. "There is no causal link established between Thimerosal and any adverse reactions to vaccines," said Eli Lilly spokeswoman Joan Todd, adding that her company discontinued the sale or use of the product about 10 years ago. "Vaccines containing the preservative have been administered to billions of children and adults worldwide with no data to suggest that the Thimerosal in these vaccines poses a public health risk," said Peter Paris, spokesman for Lyon, France-based co-defendant Aventis-Pasteur. Since October, drug companies ceased using Thimerosal in vaccines marketed in the United States, said Nancy Pekarek, spokeswoman for co-defendant GlaxoSmithKline (NYSE: GSK), the world's second largest drug company. Pekarek said the industry's action was totally voluntary. Martini, however, noted that drug companies sell Thimerosal vaccines to developing countries. GlaxoSmithKline in October also agreed to exchange any domestic inventories of vaccines with Thimerosal for new FDA-approved substitutes, Pekarek said. Pharmaceutical companies named in the suits also include: Lederle Pharmaceutical, Wyeth Pharmaceuticals (NYSE: WYE), Merck & Co. (NYSE: MRK), Parke-Davis (now part of Pfizer, NYSE: PFE), and Baxter Pharmaceutical Products (part of Baxter Healthcare, NYSE: BAX). Will federal act give some immunity? Defendants in court documents argue that such injury claims should be funneled through the fast-track, no-fault Childhood Vaccine Injury Act of 1996 that granted drug companies limited immunity from vaccine-related lawsuits. Plaintiffs' lawyers, however, counter that Thimerosal is a contaminating "adulterant" that drug companies intentionally added to vaccines. Vaccines alone don't cause injury, plaintiffs' lawyers say. It's Thimerosal. As scores of lawyers engage in civil combat, life goes on for Alex, Linda and Dennis Stewart. Day by day. For two years, Alex has attended a special school for autistic children. "He's doing very well through speech and occupational therapies and a lot of vitamins," his mother said. "Alex is very positive and does a tremendous amount of work, but it still makes my heart bleed because it's very difficult for a parent to have a special needs child on a daily basis."E-mail law writer Stephen Van Drake at svandrake@bizjournals.com. Drug Co. Lilly in lawyers' Cross Hairs Again Lawsuits suggest vaccine may be linked to autism

[By Jeff Swiatek.] http://click.topica.com/maaarooaaSNU1a4JiD8b/

No one knows for sure why autism is spreading among young children, but that hasn't stopped some trial lawyers from targeting a prime suspect in their eyes: Eli Lilly and Co. The Indianapolis drugmaker faces at least 45 lawsuits over its role in developing and selling for more than 40 years a mercury-based preservative used in childhood vaccines and now suspected of causing autism. Though the first case won't come to trial before next year, the lawsuits pose a potential costly threat to Lilly and a handful of vaccine makers also named as defendants. In an era when product-liability suits against big companies can result in jury awards in the millions or even billions of dollars, few cases can compare in jury-awakening pathos to toddlers stricken with autism. A puzzling neurological condition, autism can trigger profound mental problems in a healthy child within months and wreak havoc with families. Since the alarm was sounded in 1999 that mercury-based preservatives in vaccines might be linked to autism, trial lawyers have met regularly to plan their legal assaults on behalf of autistic children and their parents. "I think the damages are catastrophic. One case certainly could be worth millions," said Michael J. Miller, senior partner for Miller & Associates, an Alexandria, Va., law firm that's filed three lawsuits against vaccine makers and Lilly. Nationally, more than 60 lawsuits have been filed against vaccine makers, including such big firms as Aventis, GlaxoSmithKline, Merck, and Johnson & Johnson. The litigation has the potential to sign on thousands of plaintiffs, said attorney C. Andrew Waters, whose Dallas firm Waters & Kraus has taken a leading role in autism cases with more than 50 filed. Waters thinks juries will sympathize with plaintiffs who can show that drugmakers knowingly sold vaccines containing mercury in doses much higher than allowed under federal guidelines. "It just boggles the mind (how) you inject someone, much less an 8-pound baby, with one of the most toxic substances known to man." Mercury is a notoriously toxic metal that accumulates in the body and can cause severe brain damage.

Bad timing Getting caught up in the autism litigation could hardly come at a worse time for Lilly. It already faces the loss of more than $2 billion a year in revenue from Prozac, its former best-selling drug that lost patent protection last year. And it's spending millions of dollars and redeployed hundreds of workers to respond to tougher Food and Drug Administration scrutiny that has delayed approvals of at least three key upcoming drugs and forced an overhaul of manufacturing quality-control procedures. To defend itself in the autism cases, Lilly has turned to the same Kansas City law firm, Shook, Hardy & Bacon, it has used in Prozac wrongful-death lawsuits nationally and in a flurry of drug-tampering cases in Missouri. Lilly's lawyers will fight the charge that thimerosal, the scientific name for the mercury-based preservative, can cause autism, said Lilly spokeswoman Joan S. Todd. "No causal link has been established between thimerosal and adverse reactions in vaccines," she said. She criticized trial lawyers in the autism cases for "putting up these Web sites and trying to drum up business." Lilly scientists developed thimerosal (pronounced thigh-MARE-uh-sol) in the late 1920s and early 1930s and began selling it as a preservative in vaccines in the 1940s. Marketed for some uses under the brand name Merthiolate, thimerosal also has been used as a skin disinfectant and a preservative in blood, cosmetics and cleansers. Lilly stopped selling thimerosal in 1991 "because it was not a significant source of revenue," Todd said. Lilly hasn't sold childhood vaccines since the 1970s. Trial lawyers believe Lilly still is liable for damages arising from thimerosal, despite not having sold any for the past 11 years. "You can't design a product that's lethal and then just step away from it. They made an enormous amount of money on it over the years," Miller said. Waters, whose firm took the first depositions in the autism cases and may bring the first case to trial early next year, said Lilly also is open to fraud and conspiracy charges, based on evidence he dug up from the 1930s. Waters charges that Lilly "flim-flammed scientists" for years with a 1931 study that concluded thimerosal wasn't harmful to humans. The study, published in the American Journal of Hygiene, reported that Merthiolate has "a very low order of toxicity . . . for man." Digging further, Waters found out the study's toxicity data came from experimental use of thimerosal by doctors from Lilly and Indianapolis City Hospital on meningitis patients during a severe outbreak in 1929-30. The 1931 study on severely ill people ended up being "quoted in Lilly brochures into the 1980s," Waters said. "It very clearly demonstrates an effort to do an unethical study and then paint the results in a certain way that help them sell this product." Lilly ignored or covered up later evidence that thimerosal, which contains 50 percent mercury by weight, can be dangerous to humans, Waters said. Lilly's Todd said the drug firm knows of "two doctors mentioning using this (thimerosal on an experimental basis) in a study in 1929. They were not our doctors." Waters and other trial lawyers concede that the lawsuits they've filed outpace the state of science on the key question of whether thimerosal causes autism. "It is uncertain. It is controversial. It's conceivable we won't be able to establish that to the satisfaction of a judge or a jury," Waters said. He said his firm is carefully picking clients to include only children who suffered autism soon after getting injected with mercury-containing vaccines. The firm also looks for clients who have medical records showing high mercury levels in the child's body. Experts remain far from convinced thimerosal can cause brain disorders. "The evidence is inadequate to accept or reject a causal relationship between thimerosal exposures from childhood vaccines and the neurodevelopmental disorders of autism, ADHD and speech or language delay," concluded the Immunization Safety Review Committee of the National Academy of Sciences last year. As a precaution, the committee recommended the use of thimerosal-free vaccines. It also called for further study of the issue. The Autism Society of America, the nation's largest autism group for patients and their families, is following the lawsuits but hasn't publicly supported them because the science is unclear that thimerosal causes autism, said Lee Grossman, the society's president. "If there is a connection . . . why are there millions of children being vaccinated that have not gotten autism?" he asked.

"We just don't know why there's this huge explosion of children being diagnosed (with autism). Vaccines may be part of the issue, but that doesn't seem to explain the tremendous growth in numbers we're seeing. The evidence is still out." Autism affects 500,000 to 1.5 million Americans and has grown at an annual rate of 10 percent to 17 percent since the late 1980s. That span coincides with the addition of new government-required childhood vaccinations that increased the levels of mercury that children were exposed to, according to lawsuits. In Indiana, where vaccinations are now required against up to eight diseases before a child may start school, the number of autistic children registered in schools has grown from 116 in 1989 to 3,789 last year. Burton takes interest "We have an epidemic on our hands," said Rep. Dan Burton, R-Ind., in a hearing he held on the issue in April as chairman of the Committee on Government Reform. Burton has publicly suggested thimerosal might be to blame. The Indiana congressman said his own grandson Christian became autistic shortly after getting a round of childhood vaccinations in his second year of life. "Shortly after receiving his mandated vaccinations, he became a different child," Burton said at the hearing. "He no longer spoke. He would not look anyone in the eye. He cried endlessly, banging his head. He began running around flapping his hands. We now know he was suffering from an adverse reaction to his vaccines. We also know that he may have received more mercury in his vaccines than is considered safe by federal standards." Since 1999, when the FDA and other government agencies warned of potential harm from thimerosal in vaccines, manufacturers have begun supplying doctors with thimerosal-free vaccines, which are now widely used. Even so, the long use of mercury-containing vaccines left a legacy that could be costly and tragic, said Dr. James J. Bradstreet, director of research at the International Autism Research Center in Palm Bay, Fla., in a report to Burton's committee. "We must deal with the reality that our vaccine policy exposed a generation of newborns to a neurotoxin -- thimerosal." Copyright 2002 The Indianapolis Star

10/04/2002 By VALERI WILLIAMS / WFAA-TV A record number of families this year have filed cases with the nation's Vaccine Compensation Fund on behalf of children who've suffered side effects from their immunizations. More than a decade ago - with a broad spectrum of support from doctors, lawyers, families and pharmaceutical companies - Congress established the fund to help in the rare cases when there were vaccine injuries. The fund now contains nearly $2 billion - but the government is making it extremely difficult for victims to collect. Corbin Lane, 7, can't write his name or carry on a conversation. However, he CAN recite from memory at least twenty different children's books. His parents are convinced that Corbin's neurological disorder was triggered by the mercury in his vaccines. Tests show - like dozens of other American children diagnosed with autism symptoms after being immunized - Corbin has a mercury level off the chart. "He does this flexing 'stim', which looks like central nervous system damage to me," mother Donn Lane said. "But when he gets excited or upset, he'll stim. And now we can say to him, 'What are you doing?' And, he'll say, 'I'm stimming'. "We actually looked back on our videotape - he was our first child so we videotaped him like crazy. We saw it begin right around twenty months - standing in front of the TV doing it. We thought he was just excited." It was only last year that Corbin was diagnosed with Pervasive Developmental Disorder, or PDD - a diagnostic cousin of autism. Yet, his family is not eligible to apply for financial help from the Vaccine Compensation Fund because of a three-year statute of limitations. The catch is that the clock starts ticking from the first symptom of injury - not the day of diagnosis. In Corbin's case, the video shows he began having problems more than five years ago, although his parents had no clue what was happening. "I used to say 99 out of 100 parents who said their child had an adverse reaction to a vaccine were time-barred," attorney Jeff Sell said. Houston attorney, Jeff Sell, has a personal stake in the fight to get Congress to change the vaccine injury legislation. His son is autistic with extremely high mercury levels. "I'm time-barred," Sell said. "By the time I sat down and looked at my son's vaccine records, we were beyond three years and, there is an iron clad rule: Three years from the manifestation of the injury - that is an unforgivable rule." The compensation fund is set up to help injuries from all vaccines. However, within the past two years, thousands of families have come forward claiming their autistic children were hurt by a mercury-based preservative found in many vaccines called Thimerosal. Medical opponents said those families have been stirred up by lawyers looking to create a litigation bonanza in this country. Ironically, this is exactly why the Vaccine Compensation Fund received so much support - both from Democrats and Republicans - when it was established in 1988. It was supposed to be a win-win situation for families and pharmaceutical companies. Initially, the Fund had three goals: To protect vaccine manufacturers from lawsuits, to stabilize the nation's vaccine supply, and to provide generous compensation to families without tying them up in court for years. Indiana Congressman Dan Burton was one of the bill's biggest supporters, and said the fund is not working like it should. "No, it isn't at all," Burton said. "There's $1.7 billion in the fund and, instead of it being one that does not require litigation, almost every single person that we've talked to who has had children harmed by vaccines has had to fight and fight and fight to get compensation from them. "In most cases, they don't get any compensation, and when they do, sometimes it takes as much as ten years." For the past year, Burton's congressional committee on government reform has held a series of hearings highlighting the problems of a parade of parents with injured children. He and others blame the Department of Justice, which administers the Vaccine Fund, for making the process unnecessarily adversarial. Some families said that in order to collect any compensation, they've been forced into signing agreements that would keep information about their cases from being published - information that could help other parents caught in similar circumstances. "I think if you talk to the average citizen in this country whose child was dead or dying, who was suffering from lupus, and they said, 'I'll tell you what we'll do - we'll settle this thing as long as you don't publish it', I think most people would think that was unseemly (conduct) by the Federal Government," Burton said. The Department of Justice declined to comment for this report. But during the congressional hearings, officials claimed that for the past five years, they have been streamlining the process. Yet since the fund was established 14 years ago, less than a third of the 6,000 cases filed have resulted in compensation. For many families facing years of mounting medical bills, the only alternative is to do exactly what the bill hoped to prevent: file a lawsuit. In Texas alone, three law firms in Houston and Dallas have gathered nearly 5,000 vaccine injury cases. Like the Lanes, these families have nothing to lose. "You know that adage, 'We're going to force you to take this vaccine, but we don't want to be responsible for what it does to you' - that's basically what's happened," Lane said. There are at least three different bills that have popped up during the past year that would alter the Vaccine Compensation Fund. The most popular is the Burton/Waxman bill, proposed by a staunch Republican and a die-hard Democrat. The most notable change is that the bill would extend the statute of limitations to file a claim to six years. Health: TO VACCINATE OR NOT: Has a mercury-based preservative caused autism? Date: 10/7/02; Publication: Maclean's; Author: DANYLO HAWALESHKA grey divider <http://ask.elibrary.com/images/grey_hline.gif>

<http://ask.elibrary.com/images/shim.gif> Maclean's <http://ask.elibrary.com/pubminis/Maclean~Q~s.gif> 50EVERYTHING SEEMED FINE when tiny Robyn White came bouncing into the world on Dec. 12, 1994. As parents do, Scott and Jasmin White of Oakville, Ont., began taking young Robyn for her routine vaccinations. But at the age of just eight months, shortly after her first hepatitis- B shot, Robyn's eyes became crossed, she started flapping her hands and staring into space, and her hearing became hypersensitive. She never developed language skills. Last spring, her family filed a class- action lawsuit, alleging their seven-year-old's inoculation caused her autism. The suit, believed to be the first of its kind in Canada, claims that a mercury-based preservative in the vaccine called thimerosal is responsible for Robyn's neurological damage. The Whites now take their daughter to Dr. Jeffrey Bradstreet, a Palm Bay, Fla.-based autism specialist who recently testified on mercury in vaccines before a U.S. congressional committee. "It's garbage to say there's a reason to have residual neurotoxicity in an injectable for a child," says Bradstreet. "It's not a necessary risk."

Did thimerosal cause Robyn's autism? Maybe, says Bradstreet, but he doesn't know for sure. The case will take years to unravel. The Whites, however, are an example of how public trust in vaccines is on the wane. In the U.S., a raft of lawsuits claim thimerosal causes autism, attention deficit hyperactivity disorder (ADHD) and speech or language delay. The challenge is to separate medical fact from voodoo science.

Where should parents turn? Anti-vaccination Web sites tell horror stories, but a study of 22 of them published in the Journal of the American Medical Association in July found their content is largely unsupported by peer-reviewed scientific literature. Thimerosal's critics, however, are relentless in associating the agent with an apparent rise in autism rates. There could be various explanations for higher numbers of autistic children, including other environmental factors or simply an improvement in doctors' ability to diagnose the condition. Still, some respected health authorities are questioning the wisdom of injecting a heavy metal like mercury into an infant with a developing nervous system.

Thimerosal is used to prevent fungal and bacterial growth in multi- dose vials of vaccine. It guards against contamination when pediatricians jab the same vial repeatedly to vaccinate one child after another. Single-dose vials would eliminate the need for thimerosal, but they would cost more. In Canada, thimerosal-free vaccines now exist for all routine infant inoculations. But that is no reassurance for parents of children vaccinated before the use of alternative preservatives. A hepatitis-B vaccine without thimerosal became available last year, but a similar vaccine for high-risk infants born to hep-B-infected mothers still contains the compound. The diphtheria-pertussis (whooping cough)-tetanus vaccine had it until the mid-1990s. It's still in vaccines for flu, in some for meningococcal disease and in a number of special formulations for pertussis only, for diphtheria and tetanus, and for diphtheria, tetanus and acellular pertussis.

In the United States, thimerosal-free versions of routine inoculations are also available, but untraceable quantities of several common vaccines containing the substance are still in circulation. In developing countries, there is no choice: even routine inoculations contain it. David Klein, the Vancouver lawyer seeking class-action status for Robyn White' s case, suggests drug manufacturers switch to the available alternatives, "particularly when children are getting an ever-increasing number of vaccines."

Unquestionably, vaccines are one of the great medical breakthroughs of the past century. Until 1920, Canada had 12,000 cases of diphtheria annually, with 1,000 deaths. Now there are fewer than five cases a year, and no deaths. Dr. Joanne Embree, chairwoman of the Canadian Paediatric Society's infectious diseases and immunization committee, assures vaccine-wary parents that extremely small doses of thimerosal are not dangerous. "If you're worried about something that is roughly the equivalent of Elvis showing up at your doorstep, as opposed to the real risk of disease," says Embree, "then I get upset." In fact, no study has conclusively linked thimerosal-containing vaccines to neurodegeneration. Equally true, however, is that no one has studied the long-term effects of exposing children to low doses of a mercury compound that has been in use for almost 70 years.

This much is known: the human body breaks down thimerosal to form ethylmercury, a chemical cousin of methylmercury, about which more is known. In some studies, prenatal exposure to low doses of methylmercury has been associated with subtle neurodevelopmental abnormalities. In 1999, the U.S. Food and Drug Administration determined that under the recommended childhood immunization schedule, some infants risked exposure to cumulative doses of ethylmercury that exceeded some federal safety guidelines governing exposure to methylmercury. Furthermore, high doses of mercury compounds, including thimerosal, ethylmercury and methylmercury, are known to be kidney and nerve toxins. In July 1999, the American Academy of Pediatrics and the U.S. Public Health Service recommended removal of thimerosal from vaccines as soon as possible.

As public confidence eroded, the Institute of Medicine, which advises the U.S. government on public health, created an independent committee to review immunization safety. Its conclusion last October: don't give vaccines containing the preservative to infants, children or pregnant women, and do more research. "The evidence," it reported, "is inadequate to accept or reject a causal relationship between exposure to thimerosal from vaccines and the neurodevelopmental disorders of autism, ADHD and speech or language dely." Still, because such a connection was "biologically plausible," and because thimerosal has been administered in millions of doses, it should be used cautiously while research continues.

In May, Health Canada posted a report on its Web site noting that routine exposure to thimerosal in Canada has been eliminated. "As thimerosal-free vaccines come to market," said the report, "it is prudent for Canada to incorporate these products into immunization programs, to minimize to the extent possible the total burden of organic mercury exposure to children." In situations where a thimerosal-free alternative does not yet exist, the report recommended vaccination given the higher risk associated with disease.

Robyn White's lawsuit is at its earliest stage. Her father, Scott White, declined to be interviewed. Co-defendant Merck Frosst Canada & Co. had nothing to say, but a GlaxoSmithKline spokesman says the company "firmly believes there is an absence of reliable scientific evidence supporting the claim that harm is caused by pediatric vaccines containing thimerosal." A similar but separate suit against Aventis Pasteur Ltd., also filed by Klein in Vancouver, claims the firm's diphtheria-pertussis-tetanus vaccine caused autism in children inoculated in the '80s and '90s.

Ultimately, parents have to make a choice, says Dr. Paul Varughese, head of vaccine-preventable disease surveillance for Health Canada. "Would a parent prefer a child to have a disease," he asks, "as opposed to a minute amount of mercury?" Robyn's doctor bristles at the suggestion. "It's a pretty ugly choice for a parent," says Bradstreet. "Why should we put them in that position?"

Cases can take up to 5-7 years to be resolved one way or the other, by the time a parent gets denied, do you honestly think they have the resources or mental strength to then take on the drug companies, their billions, and their parade of top notch lawyers? THE DRUG SALESMAN & THE PHRMA'S DAUGHTER

Health Sciences Institute e-Alert September 23, 2002

Dear Reader,

Did you hear the one about the PhRMA guidelines?

Last summer I sent you an e-Alert ("Barbarians at the Garden Gate" 6/27/02) about the new marketing code of the Pharmaceutical Research and Manufacturers of America (PhRMA), designed to govern the pharmaceutical industry's relationships with physicians. The sweet ride was over, PhRMA said, because its new set of strict guidelines detailed exactly how far a drug salesperson could go to influence physicians to prescribe, prescribe, prescribe, and (when in doubt) over-prescribe.

But PhRMA is an advocacy group for the drug industry. They have no regulatory power, so the most they can do is to ask salespeople to stick to these guidelines on a voluntary basis.

So how do you suppose that's been working out? Influence - bought & sold

The new "PhRMA Code on Interactions with Healthcare Professionals" started off with two strikes against it: ten years ago the American Medical Association initiated similar guidelines (which nobody followed); and the PhRMA guidelines are filled with language that provides plenty of loopholes. Under these circumstances, it's easy to imagine how pharmaceutical companies might not be motivated to voluntarily pull back on the methods they've used for many years to influence and persuade their clients.

Even though the new code has been in effect for only two and a half months, the "Newark Star Ledger" decided to get the jump on everyone, reporting that some doctors claim the guidelines are being ignored. For instance, one of the PhRMA rules calls for drug salespeople to treat healthcare providers to only modestly priced meals. But the drug giant GlaxoSmithKline recently booked an expensive French restaurant to host a lecture for doctors from the University of Pennsylvania Hospital.

Similar incidents of other drug companies stepping over the PhRMA guidelines have been reported by doctors at the U. Penn Hospital. And although the Star Ledger highlighted only these isolated events, I believe we'll be hearing similar reports from other sources nationwide. And, really, did we expect not to? The PhRMA guidelines have no teeth. Their primary purpose is public relations: to show the world that the industry is at least making an effort. But while PhRMA is sending a message to the public, I hope the word is getting through to the one group that most needs to hear and understand the concept that influence should not be bought and sold: the doctors.

I'm convinced that the pharmaceutical industry can only be regulated by the health care professionals it serves. When a drug salesperson attempts to influence a doctor with gifts and other perks, there are two parties present at that point of contact. If a doctor accepts the special offers of a salesperson and in return prescribes patent drugs instead of less expensive generic drugs, that doctor is serving himself and the drug company. Meanwhile, his patients - who trust him to provide the best quality care at the lowest cost - are not being served. But if the doctor simply refuses the gifts and perks, then the problem vanishes along with the need for unnecessary regulations.

Needless to say, when your doctor prescribes a name brand drug, you should always ask if a generic is available.

But I don't want to let the drug companies off the hook here. Time and time again they've demonstrated marketing practices that would make an organized crime boss blush.

In last Thursday's e-Alert ("Taking Pity" 9/19/02) I told you how the drug companies are not above flexing their economic influence and leaning on business partners outside of their industry who might be inclined to support legislation unfavorable to the pharmaceutical conglomerates. Last week I also came across an article with this chilling headline: "Insider: Drug Safety Not FDA Priority." And guess who's right in the middle of this story, doing everything they can to press the FDA to speed along approvals of new drugs while downplaying safety issues. Did you answer "drug companies"? Right on the money!

The "insider" mentioned in the headline is Paul Stolley, M.D., M.P.H., a former FDA advisor who served as an FDA safety-consultant for two years. Now he's blowing the whistle, charging that the drug approval process is heavily influenced by drug companies who pay "product review" fees. Among other claims, Dr. Stolley says that the drug giants fully expect the reviews to speed through as quickly as possible in return for the payment of these fees.

I'm sure this story will soon be followed with additional rebuttals and accusations. So I'll keep watch for further reports, and then I'll bring you a full accounting of Dr. Stolley's insider-insights.

. A measure slipped in the homeland security bill would mean those injured by childhood vaccines could collect only $250,000.

WASHINGTON -- If the long-awaited homeland security bill passes Congress next week as expected, it could mean a big setback for parents of autistic children like 4-year-old Nicholas Liu.

Kevin and Mache Liu are among the parents of some 150 autistic children who have filed suit against the drug industry in the past two years, alleging their children's conditions were caused by Thimerosal, a mercury preservative once included in childhood vaccines designed to prevent measles, mumps and rubella.

Although the bill is intended to create a federal Homeland Security Department, it includes a little-known, last-minute amendment that will effectively end legal battles for compensation from several major drug manufacturers.

The amendment would keep the lawsuits out of state courts, preventing huge judgments, and instead send complaints to a 14-year-old federal program limiting compensation for children who suffer side effects of vaccines to $250,000. The amendment is one of more than a half-dozen tacked onto the bill. The homeland security bill has been agreed to by House and Senate leaders, but it is not expected to come to a final vote in the Senate until shortly before Congress adjourns next week.

Some Senate Democrats want to challenge the amendments, but that would be difficult because the House went home for the year after passing the bill. House members would have to be called back to Washington to approve the amended bill and get it to President Bush. House leaders have said they don't want to call representatives back. "Does this have anything at all to do with homeland security? The answer is no," Sen. Byron Dorgan, D-N.D., told the Associated Press. "This is bad legislation."

As usual, nobody in Congress is taking direct responsibility for adding the drugmaker amendment, which will save the pharmaceutical industry millions, if not billions, of dollars.

Rep. Dick Armey, R-Texas, has denied reports that he wrote the amendment at the urging of White House officials. Armey's spokesman said it came from Sen. Bill Frist, R-Tenn. Frist's aides said that while he wrote a similar provision that never passed, he had nothing to do with putting it into the homeland security bill.

Executives of Eli Lilly & Co., a leading defendant in the parents' lawsuits, say they are pleased with the amendment but have no idea how it wound up being attached to the homeland security bill. The pharmaceutical industry contributed more than $14-million to congressional candidates before the Nov. 5 election, more than three-quarters of it to Republicans. Lilly alone contributed $1.6-million, making it the most generous political donor in the industry. Democrats, meanwhile, were heavily backed by trial lawyers in this year's elections.

Attorneys for the autistic children were stunned to learn of the amendment.

"Holy smokes!" declared Jack Marstall, a lawyer in Louisiana. "I guess my 4-year-old client represents a threat to homeland security," added Charles S. Siegel of Dallas. "The industry has seized the opportunity presented by a Republican House and Senate to immediately pass legislation to get the industry off the hook," Dallas lawyer Andrew Waters told the Washington Post. "To me, it looks like payback for the fact that the industry spent millions bankrolling Republican campaigns."

Siegel's clients, the Liu family, are seeking compensation from the drug companies for medical and educational expenses, as well as for pain and suffering, on grounds the industry failed to warn parents of the potential danger of Thimerosal. No compensation figure is specified in their suit. According to Siegel, Lilly executives told top White House officials recently that their company would not participate in the administration's program to produce smallpox vaccine unless it got immunity from suits filed by those who suffer from side effects of the vaccine.

Lilly spokesman Edward Sagbiel said the allegation was "absolutely false." He said the purpose of the amendment was to "stem the tide of frivolous lawsuits" filed by plaintiffs' lawyers against pharmaceutical and other industries. Sidney Taurel, Lilly's chairman, president and chief executive, is a member of the White House Advisory Council on Homeland Security.

By executive order after Sept. 11, 2001, President Bush declared that makers of smallpox vaccine will be protected from any liability by the government if they are sued in the future for adverse reactions among patients. The administration has already indemnified Wyeth and Aventis Pasteur on that basis, and a third company is awaiting approval.

Both Sagbiel and Richard Diamond, spokesman for Armey, said the legislation was simply designed to clarify the intent of the 14-year-old National Childhood Vaccine Injury Act. Lilly has not manufactured Thimerosal for 20 years, Sagbiel said, and the industry now relies on a different preservative in MMR vaccine. Medical research has not established a link between autism and Thimerosal. Siegel said he does not understand why the drug industry needs help from Congress if their legal case is already so strong. "To say this is not an Eli Lilly bailout is ridiculous," he added.

Nicholas Liu of Pflugerville, Texas, was developing normally until he turned 16 months old, Siegel said. "Then he completely changed, as his parents say, retreating into his own world." He said the parents are convinced the change was linked to the vaccine he received from his physician.

In Canada, only the Quebec government compensates people who suffer severe injuries from vaccines. The little-known program, a form of no-fault insurance, is held up as a model by public-health officials around the world. In place since 1986, the compensation plan came about in an unusual way. The parents of Nathalie Lapierre, a girl who contracted encephalitis and suffered severe neurological damage after a measles vaccine, sued the doctor, the vaccine manufacturer and the provincial government. The case made its way to the Supreme Court of Canada and, in 1985, the claim was rejected.

However, in its ruling, the court said that while there was no legal obligation for the state to compensate, it would be an "excellent thing" to do so. "What the court said, essentially, is that people exposed to potential harm while undergoing an intervention that is in the greater public good, particularly when it is at the urging of the state, should be compensated by the state," said Yves Robert, a consulting public-health physician with the Quebec Ministry of Health. "It's hard to argue with that logic." Yet, no other province has followed the Supreme Court's advice, though Manitoba and British Columbia are looking at implementing similar plans. To date, there have been about 100 claims in Quebec, two dozen of which have been approved. All of those compensated contracted polio from a child who received the oral polio vaccine (a product that stopped being used in Canada in 1996.)

Dr. Robert said there have been claims from flu-shot recipients who developed Guillain Barré syndrome, but they have been rejected because the program is only for those who are permanently disabled. GBS symptoms are almost entirely reversible. Quebec's vaccine-compensation plan is administered by the Société de l'assurance automobile du Québec, the provincial no-fault automobile insurance program. A person disabled by a reaction to a vaccine is compensated in the same manner as a person injured in a motor-vehicle collision, using actuarial tables of earning potential and medical costs.

But unlike under the auto-insurance plan, those damaged by vaccines retain their ability to take legal action. "You can choose between a no-fault award or a civil suit, but you can't have both," Dr. Robert said. Some U.S. states have compensation programs for those harmed by vaccines, but they are funded by taxes on vaccines rather than the state.

http://www.cambridge-news.co.uk/news/news.asp?sec=1&id=332893 Parents of autistic boy in fight for MMR damages THE parents of a boy who developed autism after being given the MMR vaccination are suing its producers for thousands of pounds. Nurse Karen Goodall and her husband Peter are part of a legal action involving parents from all over the country. They are claiming unspecified damages of more than £50,000 from Merck and Co, based in Hertfordshire, for their son, Michael.

The couple, who live in Appletree Grove, Burwell, have joined other parents in the High Court action over the vaccination for mumps, measles and rubella. Mrs Goodall, 41, said that Michael, now aged 10, seemed a normal baby until he was given the vaccine at 17 months when the family was living in Plymouth. "As a nurse I believe in vaccination. My daughter Natalie, who is three years older than Michael, had it and was fine," she said. "Michael was walking before he was a year old and was chattering away as most little ones do. But after he had the MMR it all stopped. He wouldn't respond and he wouldn't look at us."

Michael, who was diagnosed as having autistic tendencies in February, 1995,now attends a special school, Green Hedges at Stapleford. But when he is not at school he requires 24-hour attention. "He does not speak and he gets very frustrated and agitated when he can't make himself understood," said Mrs Goodall. "He is 5ft tall and weighs eight and a half stone and has smashed four doors in the house as well as no end of videos. He has no sense of danger so we have to watch him all the time.

"I can only work part-time because of the need to look after him. "I understand why the Government wants people to give their children the vaccine. But the incidence of autism is so high now that I want 100 per cent proof that it isn't caused by the vaccination."

She said that she and her husband hoped to win damages to pay for Michael's future care.

Law Firms Continue Thimerosal Litigation WASHINGTON, Nov 26, 2002 (BUSINESS WIRE) -- http://www.stockhouse.com/news/news.asp?tick=LLY&newsid=1419209 A consortium of law firms representing children exposed to mercury in vaccines, led by attorneys Michael Williams, of Portland, Oregon, and Richard S. Lewis of Washington, D.C., have vowed to continue litigation against manufacturers of thimerosal, a mercury-based preservative found in some childhood vaccines, despite the "Eli Lilly" rider attached to the Homeland Security Bill and signed into law by President Bush yesterday. The national consortium, lead by Williams, of Williams, Dailey, O'Leary, Crane & Love, and Lewis with Cohen, Milstein, Hausfeld & Toll, is seeking to have vaccine manufacturers set up court-administered funds that would allow children to get needed medical tests in order to mitigate potential neurological damage caused by thimerosal exposure. Thimerosal, which is fifty percent mercury, was added to vaccines to prevent bacteria contamination when a doctor repeatedly drew vaccine doses from the same vial. After scientists and parents raised concerns about injecting children with mercury, thimerosal was taken out of vaccines in the late 1990s. Lawyers contend, however, that thimerosal and vaccine manufacturers' documents indicate that these companies knew about the health problems associated with thimerosal since at least the early 1970s. The Institute of Medicine has also concluded it is "biologically plausible" that thimerosal is causing neurodevelopmental disorders. While the rider attached to the Homeland Security Bill forced thimerosal personal injury claims into the Vaccine Injury Compensation Program, a federal program designed to protect vaccine manufacturers from liability and reduce compensation levels for victims, the rider will not have any effect on cases seeking "medical monitoring" injunctive relief which gives medical tests to children, not cash awards. Lawyers contend, however, that it is likely that lobbyists will push for additional special interest legislation in the new session of Congress to wipe out the medical monitoring cases, completely depriving mercury-exposed children of any remedy in the court system and shutting down fact investigation into what the drug companies knew about the dangers of thimerosal and when they knew it. Richard S. Lewis responded to the Homeland Security Bill signing by stating that, "We are troubled that this provision was made a part of this bill; we will actively continue our efforts to seek testing for kids who were exposed to excessive mercury levels so that we can mitigate brain damage before it becomes irreversible." Michael Williams added, "The `Eli Lilly' rider merely reinforces the importance and public health necessity of this law suit. The back-room deal that put these anti-child amendments into the Homeland Security Bill is just the first step in the drug companies' efforts to completely avoid any responsibility for what they did to a generation of children." Other members of the consortium include: Larry Cohan of Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley in Philadelphia, Pennsylvania; Tobias Millrood of Schiffrin & Barroway in Philadelphia, Pennsylvania; and David Klein of Klein and Lyons of Vancouver, British Columbia, Canada. By Ori Twersky

WASHINGTON (Reuters Health) Dec 04 - The growing number of vaccine-related autism claims could threaten to overwhelm the US government's tax-based injury compensation program and force it into entering numerous costly settlements despite the lack of an established connection, according to federal officials.

Created by a congressional act in 1986, the National Vaccine Injury Compensation Program was designed to provide individuals injured by a vaccine with compensation while limiting litigation and keeping vaccines widely available. The rationale was that vaccines would always be easy targets for litigation because they have inherent side effects and almost everyone is vaccinated.

At question now is whether the program will be able to withstand a potential flood of new claims, alleging that the once commonly used vaccine preservative thimerosal caused hundreds of American children to develop autism, officials from the US Department of justice (DOJ) told the HHS Advisory Commission on Childhood Vaccinations on Wednesday.

Thimerosal is no longer used in most childhood vaccinations, and its alleged connection to autism has not been established. But a recently passed federal law has now effectively ensured that virtually all such existing and future claims would be filed under the federal compensation program, the officials noted before a Department of Health and Human Service (HHS) advisory committee.

Passed as a provision of the Homeland Security Act, the November law extended the vaccine liability protection to manufacturers of vaccine components such as thimerosal. As in 1986, the rationale was that such liability protection is needed to ensure that the US will always have adequate access to needed vaccines.

Justice officials deny that the newly passed law actually served to change the landscape. "It was always our view that even under the old law, they (the litigants) had to come here first," Mark W. Rogers, assistant director of the DOJ's Torts Branch, told Reuters Health.

But the number of actual claims filed so far and the expected number of new claims filed because of the Homeland Security Act is raising some concern that such claims could overwhelm the system, he said. "We simply don't know," Rogers said. "It will all depend upon the number of claims filed."

Still, federal figures paint a potentially grim picture. Thanks in large part to the thimerosal controversy, the number of claims filed under the compensation program grew more than four-fold in fiscal 2002, according to the federal figures, and are on record pace for the fiscal 2003 year that began in October.

At present, the government is trying to establish whether such claims have any merit, making them eligible for out-of-court settlements.

"We cannot litigate thousands of cases," explained Gary Golkiewicz, a representative of the US court that adjudicates such claims, to the government advisory committee. "There have already been about 1,100 petitions filed and who knows how many more are coming."

Golkiewicz said until specific standards are established for judging these cases, the court was also likely to continue struggle, making the no-fault out-of-court settlements more likely. "The present game plan is to try to isolate it," he said. "Keep the chaos in one corner." Even if a connection is never established, the sheer number of claims could force such out-of-court settlements, Golkiewicz said. "These autism/thimerosal cases are going to test the program, stress the program," he said.

On the plus side, the program is solvent and has reserves amounting to about $1.8 billion, said Thomas E. Balbier, Jr., director of the of Vaccine Injury Compensation division at HHS. As of November, there were also only six outstanding claims dating from before 1988, suggesting that the government is moving faster to adjudicate these claims and get them resolved, he said. Omitting controversial claims such as the autism cases, the average time to closing on such claims has been reduced to about 11 weeks, Golkiewicz said. "The vital signs are otherwise good," he said.

MMR deaths awarded by VDPU but denied by UK government "Jabs has also had reports of 24 deaths, which contrasts with the government's claim of parents that one dose of MMR does not cause death. The VDPU, for example, has made a payment to the parents of Hannah Buxton, who died of a massive fit after receiving MMR at 18 months. The parents of Chloe Dwyer, who died of Guillaine-Barre syndrome after receiving her first MMR at four-and-half, also secured a payment. As Jackie Fletcher of Jabs said: "The drug companies acknowledge side effects; scientific studies shows there have been side effects. Parents report them. But the government says it can't happen."--Private Eye MMR Report p13 May 2002 "Despite this, the Department of Health insists no child has ever died from MMR." http://www.whale.to/v/mmr101.html "The conclusion time and time again is that the (MMR) vaccine is safe." Dr Elizabeth Miller Public Health Laboratory Service, 22 January, 2001

A Birmingham woman with two autistic children is joining more than 1,000 people in a UK-wide legal claim against the makers of the MMR jab. Charlene Ward, of Bartley Green, says she is delighted that Alexander Harris solicitors has agreed to fund her claim against Aventis Pasteur, SmithKline Beecham and Merck & Co. The move follows a blunder at Bellevue Medical Centre, in Ladywood, in which eight-week-old Shannon Whitter was accidentally given the MMR vaccine.

Mrs Ward, whose sons Shane, aged eight, and Adam, 14, have autism, said: "I'm so relieved that we are going to be able to join this group action. "We want to drag the manufacturers of this vaccine through the courts. "They are experimenting with their precious MMR vaccine and it is our children who are the victims. "Shane is going to need care long after my husband and I die, so he will need as much compensation as he can get."

A spokesman for Alexander Harris said: "More than 3,000 people have contacted us with complaints about MMR and Mrs Ward is one of 1,000 that we have agreed to take on. "In the first instance, we have to prove that the MMR vaccine has caused damage to a range of children and then we will be able to assess every individual case."

In 1992 Alexander Harris solicitor Richard Barr was contacted by a concerned mother whose son had developed autism after receiving the vaccine. Since then, the law firm has beenfloodedwithcalls from parents complaining of bowel problems, autism, epilepsy and brain damage in their children following the jab. The Department of Health continues to point to conflicting evidence which rules out a connection between autism and MMR. The case will be heard at the High Court in October 2003.

After the Bellevue blunder Shannon's parents, George Whitter and Christine Fullen, took her to hospital where she was given the all-clear, but doctors said she might suffer mild side effects.

WASHINGTON (Reuters Health) - Attorneys for the Bush Administration asked a federal court on Monday to order that documents on hundreds of cases of autism allegedly caused by childhood vaccines be kept from the public.

Department of Justice lawyers asked a special master in the US Court of Federal Claims to seal the documents, arguing that allowing their automatic disclosure would take away the right of federal agencies to decide when and how the material should be released. Attorneys for the families of hundreds of autistic children charged that the government was trying to keep the information out of civil courts, where juries might be convinced to award large judgments against vaccine manufacturers. The court is currently hearing approximately 1,000 claims brought by the families of autistic children. The suits charge that the measles-mumps-rubella (MMR) vaccine, which until recently included a mercury-containing preservative known as thimerosal, can cause neurological damage leading to autism.

Federal law requires suits against vaccine makers to go before a special federal "vaccine court" before any civil lawsuit is allowed. The court was set up by Congress to speed compensation claims and to help protect vaccine makers from having to pay large punitive awards decided by juries in state civil courts. Plaintiffs are free to take their cases to state courts if they lose in the federal vaccine court or if they don't accept the court's judgment.

The current 1,000 or so autism cases are unusual for the court. Because it received so many claims, much of the fact-finding and evidence-gathering is going on for all of the cases as a block. Monday's request by the Bush Administration would prevent plaintiffs who later go to civil court from using some relevant evidence generated during the required vaccine court proceedings. Plaintiffs' attorneys said that the order amounted to punishment of the families of injured children because it would require them to incur the time and expense of regenerating evidence for a civil suit.

"Wouldn't it be a shame if at the end of the day our policy would be to compensate lawyers," said Jeff Kim, an attorney with Gallagher Boland Meiburger & Brosnan. The firm represents about 400 families of autistic children who received the MMR vaccine.

Kim accused the government of trying to lower "a shroud of secrecy over these documents" in order to protect vaccine manufacturers, who he said were "the only entities" that would benefit if the documents are sealed. While federal law clearly seals most documents generated in individual vaccine cases, it has never been applied to a block proceeding like the one generating evidence in the autism cases. Administration lawyers told Special Master George Hastings that they requested the seal in order to preserve the legal right of the Secretary of Health and Human Services to decide when vaccine evidence can be released to the public.

Justice Department attorney Vincent Matanoski argued that to let plaintiffs use the vaccine court evidence in a later civil suit would confer an advantage on plaintiffs who chose to forgo federal compensation. "There is no secret here. What the petitioners are arguing for are enhanced rights in a subsequent civil action," Matanoski said of the plaintiffs. "They're still going to have unfettered use within the proceedings." Hastings would not say when he would issue a ruling on whether to seal the court documents, but did say that his decision would be "very prompt."

PRNewswire via COMTEX - The US Department of Justice agreed today to withdraw its motion to the US Court of Federal Claims Office of Special Master to seal all documents related to present thimerosal-autism claims. The Mercury Policy Project and SAFE MINDs said that the withdrawal of the motion was a step in the right direction. However, the groups questioned whether documents in future cases would be subject to the secrecy order. "The Bush Administration has overreached in its attempt to seal documents in thimerosal cases and the withdrawal of their motion bears that out," said Michael Bender, director of the Mercury Policy Project. "Unfortunately, this agreement only addresses half the loaf of bread. While the motion's withdrawal may help those involved in current litigation, it leaves unresolved what this means for future cases."

While the groups acknowledge that some information unearthed in court should be kept private -- like trade secrets -- they maintain that scientific studies and information should not qualify. In addition to the documents obtained through discovery from Eli Lilly, these also include unreleased confidential documents from the Centers for Disease Control stating that mercury in children's vaccines is a potential source of neurological damage in children including ADD/ADHD, speech and language delays and other neurological disorders including autism.

"We question the Bush Administration's blatant attempt to hide from the American public documents affecting the health and safety of millions of children -- especially when the material in question is as dangerous as mercury," said Lyn Redwood, Pres. SAFE MINDs. "What are they trying to hide?"

While federal law typically seals documents in individual cases, it has not been applied to omnibus proceedings like the autism cases. "What's the policy argument for such incredible secrecy?" said Sallie Bernard, executive director of SAFE MINDs. "The timing and the scope of this unprecedented secrecy action by the Bush Administration raises serious questions, considering that lawmakers have pledged to revisit the thimerosal liability shield provision in the Homeland Security Act when they return in January."

"The Bush Administration's secrecy request was premature, highly unusual and went against federal rules that impose severe restrictions on sealing of documents," said MPP director Bender. "The public -- and especially families of autistic children -- have a right to know about what Eli Lilly knew and when they knew it, both now and into the future." The Mercury Policy Project and SAFE MINDs are non-profit organizations dedicated to reducing and eliminating mercury exposure and improving children's health and environmental outcomes through the elimination, treatment, and scientific investigations of mercury, regardless of its source, including thimerosal in medical products. More information is available at http://www.safeminds.org or http://www.mercurypolicy.org

AN EIGHT-YEAR-OLD Wakefield boy is suing a global drugs firm for damages of more than £50,000 over a claim that a vaccination left him brain-damaged.

Elizabeth Radunovic, of Highfield Crescent, Overton, claims son Karl developed cerebral palsy and Asperger's syndrome a mild form of autism after having the triple vaccination for diphtheria, pertussis and tetanus (DPT) when he was six weeks old. The family is now taking on pharmaceutical giant GlaxoSmithKline in a legal battle to help pay for his future care. Mrs Radunovic, 46, told the Wakefield Express: "About two hours after his vaccination he started crying, which turned into high-pitched screaming. I phoned the doctor and he came to see Karl. We couldn't calm him down and the doctor said it could have been a reaction to the vaccine."

Karl was taken to hospital. "They discharged him and after that there was a total change in him," she said. "They kept saying he was a lazy baby but he was referred to a specialist and he was diagnosed with cerebral palsy and Asperger's syndrome. "We were devastated at the time, and horrified." The Middlestown Junior and Infant School pupil's balance is affected and he is weak down his left side. His Asperger's syndrome causes behavioural problems and means he is unable to concentrate. Mrs Radunovic said Karl's behaviour was under control but the future was uncertain. "What he's going to be like when he gets older we don't know. "It has put a big strain on the family. The claim is for his future care." But the family's case, which is due to be heard at the High Court in January, needs legal aid. Mrs Radunovic, a veterinary receptionist who looks after Karl with husband Michael, a 47-year-old engineer, said: "If you break the law in this country you get legal aid. But these children didn't ask to be vaccinated. "When something has gone wrong the company should accept responsibility and sit up and listen and make sure it doesn't happen in the future."

Mrs Radunovic's London solicitor Peter Todd said the case was at an early stage. He added it would cost millions and would not go ahead without legal aid. Karl is one of 120 disabled children suing the Wellcome Foundation, part of GlaxoSmithKline, for personal injury and consequential loss and damage allegedly suffered as a result of the vaccine. GlaxoSmithKline is facing a separate claim by thousands of children who allegedly developed autism after receiving the company's measles, mumps and rubella (MMR) vaccine. A spokesman for GlaxoSmithKline said: "This is a routine hearing asked for by the court, which we believe wants to look at the timetable because there have been delays. "These delays are not of our making." I guess Golkiewicz characterizes all hep B vax injuries as "controversial" too, since it wasn't even included under the umbrella of compensable vaccines until August 1997. Many of us had that vaccine at least a decade ago and are still waiting for our court dates. What about those 6 claimants who've been waiting >14 years?? That's ridiculous.

Anyone who has yet to engage in practice governed by the National Childhood Vaccine Injury Compensation Act, a step required for all current vaccine injury and death claims as a condition precedent to litigation in a private forum, should proceed with great caution. Though the Congressional intent was to create a victim-friendly statute which provided just and fair compensation quickly and without the uncertainties and proof problems inherent in civil actions, frequent practitioners under the Act are in virtually universal agreement that the program, as it has evolved during the past decade and a half, is a perversion of the Congressional intent.

It certainly does not take into consideration the injury suffered by the victim (usually an infant or child), the emotional and psychological effect of the child’s injury on the parents, or the quantity of work which an attorney with a case before the Claim Court must accomplish to have any reasonable chance of prevailing on such a claim.

Unmistakably, pursuing a claim through the Act’s process is tantamount to litigation in every sense. The only difference is that instead of the vaccine manufacturer, the “defendant” is the United States of America. The lawyers representing the United States are, of course, from the Justice Department, and the Special Masters assigned to hear these matters are employees of the federal government.

The Special Masters uniformly follow established goals of examining the issues presented in an individual case, unaffected by the reality that the United States is their employer. Since they are constantly dealing with tragic events, they feel themselves bound to strictly interpret the administrative procedures for evaluation of claims, not necessarily to the benefit of the victim, but rather to harmonize with prior Claims Court opinions involving matters that arose in unrelated legal contexts.

Equitable tolling is not available under the Act. Under the Federal Tort Claims Act, if an individual injured by a vaccine could prove that the government violated the 21 C.F.R. regulations applicable to that vaccine, it would be entitled under Berkovitz v. United States to bring a non-jury federal tort claim. Many such civil actions have been brought in the past: Berkovitz v. United States, 486 U. S. 531; Griffin v. United States, 351 F.Supp. 10, aff’d, 500 F.2d 1059 (CA3 1974); Loge v. United States, 662 F.2d 1268 (CA8, 1982); In Re Sabin, 763 F.Supp. 811 (D.Md. 1991); St. Louis University v. United States, 5 Fed. Appx. 133 (CA4 2001); Baker v. United States, 817 F.2d 560 (9th Cir. 1987).

If a victim of the government’s negligence could not discover, and did not discover, that it was the government’s negligence, at least in part, which caused that plaintiff’s injuries, the court would evaluate the claimant’s basis for asserting the doctrine of equitable tolling. Proofs would have to be offered as to why that individual had not commenced the action within two years from the first sign of injury, preliminary motions would be brought and hearings held, and discovery would take place to determine whether or not the plaintiff does or does not fit the criteria of cases such as United States v. Kubrick, 444 U.S. 111 (1979); Tyminski v. United States, 481 F.2d 257 (3rd Cir. 1973); Ciccarone v. United States, 486 F.2d 253 (3d Cir. 1973); Zeleznik v. United States, 770 F.2d 20 (3rd Cir. 1985.

When that same plaintiff brings an action under the ostensibly victim-friendly Act, no excuse for a late claim is acceptable. Equitable tolling is not permitted: if the claim was not brought within three years from the date of the occurrence, the claim is barred, and any hope of a private damages action in the event an unacceptable claims resolution follows is destroyed. Brice v. Secretary HHS,240 F.3d 1367 (Fed. Cir. 2001). See, also, Hebern v. Secretary HHS, 01-0361V. The Brice decision was not based on federal tort claim practice, but rather in reliance on the holdings of two run-of-the-mill cases, Johns-Manville Corporation v. United States, 893 F.2d 324 (Fed. Cir. 1989); and Irwin v. Dept. of Veterans Affairs, 498 U.S. 89 (1990).

Amending the Act to permit equitable tolling has been discussed recently, but to date, the Secretary of Health and Human Services has not actively supported new legislation which would accomplish that goal.

Death of the Petitioner: Compensation Bonanza for the Government, Its Department of Justice and the Regulatory Agency

Assume the following scenario: A child was given the oral polio vaccine; the father (wage earner), changes the child’s diaper and he becomes paralyzed from the neck down because the vaccine administered causes contact polio, a fact known both to the regulator, the vaccine manufacturer and physicians since the early 1960s.

The parent remains completely paralyzed with his motor functions completely destroyed, while his sensory functions are not affected one iota. Basically, he can only move his eyes. The medical expenses for the first 18 months are nearly $1 million, but he has no insurance. During the 18 months he is aware of everything, but he cannot move any of his limbs or any part of his body, other than his eyes. Eventually, the polio causes respiratory failure and he dies.

It is now time to bury this innocent victim. His widow has no money, since no income was coming in for the last 18 months. The government/respondent not only will not pay for the funeral, it won’t even pay for the burial plot. The government/respondent’s position is very simple — if you die the only thing the estate is entitled to is $250,000; the $1 million in medical expenses are the obligation of the widow. The costs of the burial and the burial plot are the obligation of the widow.

The fact that during those 18 months the widow, the children and the husband suffered unbelievably, and the widow and the children will continue to suffer for all the years to come, is unimportant. It is not compensable. A victim who dies as a result of the vaccine receives no money for the pain and suffering no matter how long they lived or how severe the suffering was for that victim. This is not a hypothetical case, but rather a recent decision handed down in the case of Clifford v. Secretary of the Department of Health and Human Services, July 30, 2002, No. 01-424V.

The Act’s Legal Position

The legal position of this “victim friendly Act” can best be summarized by reviewing a portion of the Government’s refusal to pay a funeral bill for a child who was administered the MMR vaccine, who lingered for nearly a week suffering a major encephalopathy, and then expired. The Government was requested to pay the funeral bill; it refused and advised the Special Master of the following:

The Vaccine Act states that compensation for a vaccine-injured claimant’s future, unreimbursable, vaccine-related expenses is limited to “diagnosis, medical or other remedial care, rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary.” 42 U.S.C. §300aa-15(a)(1)(A)(iii)(I)(II). This provision has been found to be an “exhaustive list” of the compensatory expenses allowable under the Vaccine Act. Potter v. Sec’y, HHS, 22 Cl.Ct. 701, 704 (1991); Hulsey v. Sec’y, HHS, 19 Cl. Ct. 331, 334 (1990). Thus, since future unreimbursable burial costs are not listed as a compensable expense under section 15(a)(1)(A), they cannot be awarded by the Program…no vaccine case has awarded petitioner’s burial costs as a compensable expense under section 15…

In death cases, Congress authorized an award of $250,000 “for the estate of the deceased.” 42 U.S.C. §300aa-15(a)(2). This statutory limitation is amplified by the legislative history, which specifies that “allowable death benefits for a vaccine-related death are set at a level of $250,000.” H.R.Rep. No. 99-908, 99th Cong., 2d Sess., reprinted in U.S. Code Cong. & Admin News 2313-2661 (1987) (emphasis added).

In keeping with the statute’s plain meaning, the Court of Federal Claims has construed section 15(a)(2) as precluding an estate from receiving anything other than the expressly permitted death benefit. Sheehan v. Sec’y. HHS, 19 Cl.Ct. 320, 312 (1990) (“because compensation for vaccine-related deaths are explicitly limited by the plain language of section 15(a)(2)…this court will not now reach beyond that clear statutory mandate to award additional compensation…”). Even if one were to assume that compensation in addition to the statutory death benefit were available to a decedent’s estate, such an award should logically be limited to the categories of compensation listed in section 15(a)(1)(A).

As noted previously, the cost of burial expenses is not on the list of compensable items for a vaccine-injured claimant under section 15(a)(1)(A). Accordingly, the claim for unreimbursable funeral expenses in this case should be denied.

Experts’ Fees

What more need be said? This is not a victim friendly Act; it is just good old fashioned litigation with limited, nominal financial protection for the injured, the dead and their survivors. The deck is stacked against the petitioner and their counsel. It is in the respondent/U.S. Attorney’s hands to determine when and if petitioner’s experts will be paid.

The respondent’s experts are always paid. It is in respondent’s hands to determine how much petitioner’s expert will be paid. The experts hired by the respondent are guaranteed their hourly charge. Respondents determine how much of a fee counsel for petitioner will receive for representing the petitioner, the widow and the surviving children. Respondents will determine if the fee is reasonable. The respondent will determine the reasonableness of your fee and the reasonableness of the hours spent preparing for the ultimate trial of the matter.

If fairness and equity were the Congressional mandate, the Act is a complete failure. If it is prompt and complete restitution to make the injured child, infant, and/or adult able to be in the same position as if the unfortunate adverse reaction had not occurred, it is a failure. The Act does not use equity, fairness and reasonableness as the criteria.

As the special master stated in Clifford, supra, at page 8-9 of her opinion:

Due consideration of the above legislative history and case law compels the undersigned to conclude that petitioner in the instant action is entitled to an award solely of $250,000 plus reasonable attorney’s fees and costs. She may feel this is an unfair result, but it is consistent with the Act.

Congress, in creating legislation termed the National Childhood Vaccine Injury Act, may not have contemplated its applicability to adult vaccinees who were wage-earners when it enacted the provision determining $250,000 as the death benefit. Congress also seems not to have envisioned instances where a vaccinee of any age had prolonged hospitalization before dying from a vaccine injury. Redress in the civil courts is an option in those cases in which economic loss and/or hospitalization costs far exceed the statutory death benefit. Section 300aa-21(a) permits petitioner to elect to file a civil action for injury or death.

After nearly four years, the special master tells the litigant - if you want fairness and you want the bills paid, the Vaccine Act is not the solution.

About the Author

Stanley P. Kops is principal of The Law Offices of Stanley P. Kops in Bala Cynwyd, Pa. Kops has been involved for years in polio litigation, with both the vaccine manufacturer and the United States of America, in connection with cases involving paralytic poliomyelitis caused by the oral polio vaccine. He currently represents plaintiffs allegedly injured by SV40-containing polio vaccines.

FROM THE INDIANAPOLIS STAR

http://www.indystar.com/print/articles/3/019358-1213-P.html

Vaccine victims forced to wait

'No fault' settlement system may change as claimants get sick of delay in compensation.

By Maureen Groppe

mgroppe@gns.gannett.com

January 31, 2003

WASHINGTON -- Betty Fluck is still waiting to find out if the federal government will compensate her for a hepatitis B vaccine that she believes is responsible for her persistent pain. The government set up a program in the mid-1980s to help the small percentage of people who have a serious reaction to a vaccine, but Fluck and others like her have been complaining for years that the program is too slow and too adversarial.

It is increasingly likely that Congress will change the program this year, but not necessarily in the ways families want. That's because drug companies, including Indianapolis-based Eli Lilly and Co., have been complaining, too. The industry is worried that victims and their families have found a way around the federal program, which was meant to resolve claims against vaccine manufacturers without costly court battles.

Fluck, a registered nurse from Kokomo, said that 12 hours after getting vaccinated as a work requirement in 1997, she awoke in the middle of the night screaming in pain with swollen joints and a 104-degree temperature. Her fever subsided, but Fluck couldn't move her legs. After years in leg braces, she now walks with a cane and can't work. "Before I was injured, I could kick a 6-foot-tall man in the head," the former karate enthusiast said. "Now I can't even lift my leg off the ground 6 inches."

And, like many other claimants, she has been waiting for compensation that is slow in coming. More than $1.4 billion has been distributed since the federal compensation program began making payments in 1988, with an average payment of around $800,000. So far, about 1,700 families nationwide have received payments. There is no specific payment figure for Indiana.

The program is sitting on a balance of $1.8 billion collected from a 75-cent tax on each dose of vaccine purchased. Some of that money has been loaned to other federal programs. Claimants are supposed to apply to the fund first and sue only if they are unhappy with the outcome. But some families who believe the vaccine preservative thimerosal has caused autism or other neurological injuries have gone straight to court, arguing that vaccine additives are not the same as the vaccine itself.

At least 100 lawsuits have been filed that allege injuries were caused by thimerosal, which contains mercury. Lilly, once the largest manufacturer of thimerosal, no longer makes the product. Republicans slipped language into a homeland security bill last November making vaccine preservative and additive claims part of the compensation program. That would have invalidated the lawsuits against drug companies, including Lilly.

But a public outcry forced lawmakers to announce this month that they will repeal the provision in the big spending bill Congress must pass to finish up last year's budget work. That could happen as early as next month.

Lilly officials have said they hope any effort by lawmakers to revamp the federal program will include language clarifying that vaccine-preservative injury claims should be handled by the government's vaccine court. "The lawsuits that have been filed against Lilly and other manufacturers are not supported by science," the company said in a statement. Senators agree that the entire vaccine program should be examined.

"If we allow out-of-control lawsuits to drive people out of the business of making these vaccines," Senate Majority Leader Bill Frist, a surgeon, said, "we will not be able to make vaccines which are critically important."

The program was supposed to be a nonadversarial, "no fault" system that compensated families without their having to meet higher levels of medical proof required in civil courts. Instead, most claims take twice as long as the one year that was anticipated. Some have dragged on for a decade. Families say it is difficult to find lawyers to file their claims because settlements can take so long.

Some lawmakers are pushing to increase the payment for a vaccine-related death to at least $300,000 from $250,000, increase the time a family has to file a complaint to six years from three, and allow attorneys to get some payment while the claim is being processed. The Bush administration supports some of those changes but is against a proposal by Rep. Dan Burton, R-Ind., to give families who have missed filing deadlines a two-year window to make a claim. Burton's proposal primarily would help families who believe thimerosal injured their children but who received the vaccine years before there was speculation about a connection.

"It would do so much to help families who just didn't know much about the program," Burton said. Burton, who believes the vaccine is responsible for his 4-year-old grandson's autism, has become the biggest advocate on Capitol Hill for the families of those injured by vaccines. He says his grandson's family has applied to the federal vaccine fund and is facing frustrations common among many claimants.

"They're just jerking him around," Burton said.

The government is trying to figure out what to do with thimerosal claims, which have more than tripled the number of petitions filed. Those filings increased from 214 in 2001 to at least 790 in 2002. So far, no payments have been made on thimerosal-related claims. Thimerosal has not been proven to cause autism or other neurological conditions and is not one of the injuries for which compensation is easy to obtain. For that and other reasons, many families have chosen to sue vaccine makers instead. Litigation is also difficult, but the payout is probably bigger.

Fluck said she doesn't know if vaccine court petitioners would be better off taking their chances in civil court, because then they have to go up against the pharmaceutical industry's lawyers. "Basically, we just want them to admit there's a problem and help the victims," Fluck said. "They need to fix this fund."

THE family of a nine-year-old boy said to have been left with severe health problems after an MMR jab is fighting for more than £1m compensation. Nathan Wilson and his relatives are among hundreds of claimants mounting a joint legal bid to try to force the makers of the vaccine to admit it caused problems such as inflammatory bowel disease, autism and other conditions. Legal experts say if the case is successful, it could mean children like Nathan being in line for more than £1m each, according to the extent of their health problems.

A trial of the issues around the MMR cases is due to start at the end of the year. An individual writ by the Wilson family for damages has been issued against manufacturer Merck and Co Inc in the High Court. Both the Department of Health and Merck and Co Inc, maintain that the jab is safe. However, many families across the country are turning down the joint mumps, measles and rubella vaccine in favour of individual jabs because of health fears.

Nathan, from New Mills, was a normal child when was given the vaccine at the health centre in the town when he was 14-months-old. His parents say that he changed within weeks, developing severe learning and behavioural problems and attention deficit disorder. They blame the jab, saying there can be no other explanation. Now they are determined to pursue the manufacturers and do all they can to force the government to order further tests on the vaccine. Their case is being handled by the London-based Hodge, Jones and Allen company.

Nathan's mum, Pauline, 37, said: "Nathan is a lovely little boy and is so happy in his own little world, but he is also very demanding because he has very limited speech and severe learning and behavioural difficulties. "We noticed a problem within weeks of him having the jab and now he depends on us for everything." Nathan's dad, 42-year-old Alastair, added: "This issue cannot be swept under the carpet any longer." The Department of Health maintains the jab is safe and says children are more protected by having it than the single vaccines or none at all. More than 1,000 families who claim MMR has damaged their children are being represented by Manchester medical negligence specialists Alexander Harris.

Its basic principle is sometimes referred to as the Butterfly Effect -- as in, say, a hurricane being whipped up by ever-increasing wind vectors over a period of days and weeks after being catalyzed by the tiniest imperceptible change in air current when a butterfly somewhere flaps its pretty little wings.

Our ancestors perceived this basic idea without naming it. It often appears in venerable literature and verse: "For want of a nail, the shoe was lost; For want of a shoe, the horse was lost; For want of a horse, etc. ... " You get the picture. A tiny nail goes missing and a kingdom topples. This theory of seemingly random cascading events is scoffed at by some academics, but I'm starting to believe in it.

How else to explain a formative scintilla of hatred in a formative mind in a desert nation somewhere three or four decades ago sparking the current imminent danger that a basic taken-for-granted freedom will soon be lost to all Americans? I'm talking about the traditional right of redress for unfair physical injury by seeking fair adjustment in an American court. Yours could evaporate soon.

Among vaccine safety advocates and much of the legal profession the suspicion is that big pharmaceutical companies are using Sept. 11 and its aftermath of constant terrorism warnings as a cloak to protect themselves against future such litigation -- justified or not, connected to terrorism or not. Congress is about to grant such permanent waiver of liability.

Here's the background.

In the early 1980s, drug companies were being snowed under by costly lawsuits over deaths and serious debilitating reactions to certain vaccines. They threatened to stop making the vaccines if they didn't get protection from liability claims. In 1986, Congress created a compromise -- the Vaccine Injury Compensation Program.

Under it, dead and damaged children and their parents would be compensated without costly litigation against the drug companies by showing causation and reaction under an established table of injuries. The program was funded by a very small fee paid by the parents and attached to each vial of the many vaccines children receive these days. It mounted up. By the new millennium, the fund held more than a billion dollars. Out of the millions and millions of infants and toddlers given shots over the years, there have been about 7,600 applications for compensation by victims of childhood vaccinations, but only 1,800 awards.

The program was considered a great success until 1995, when the Department of Health and Human Services -- pressured by pharmaceutical lobbyists seeking to limit even that meager number of awards -- quietly changed the table of injuries and "compensable events" and raised the causation standards to a very high bar, one almost impossible to clear. At the same time, the Department of Justice started sending over tough veteran trial attorneys to defend the allegedly no-fault federal program against all comers as if the fund were Fort Knox and the damaged children were masked burglars.

Parents who wandered into the compensation thicket without a seasoned tort attorney discovered themselves trapped in a process even more adversarial than the court system, and they were usually wiped out by the Justice lawyers. Despite a growing wave of claims, two of three children who now apply for financial help with their vaccine injuries are denied.

The 1986 law respected the basic legal privilege of citizens by leaving clear access to the civil tort system -- the freedom to sue vaccine manufacturers or negligent doctors -- if the child was turned down for compensation. Only a handful of such vaccine injury lawsuits were brought since the compensation program was established.

That is, until the last few years, when the rates of severe childhood autism began to double and triple annually in some regions. Tort lawyers, vaccine safety advocates and many medical researchers suggested the reason was increased use of certain childhood vaccines that contained, as preservatives, mercury compounds found in separate research to cause brain damage, chronic neurological dysfunction and lasting insult to the immune system.

The most frequently used preservative compound in question, thimerosal, contains mercury, and tort lawyers have some heavy federal artillery available in preparing any vaccine injury complaints stemming from such inoculations. The American Academy of Pediatrics, the U.S. Public Health Service, the Food and Drug Administration,and the Institute of Medicine in recent years have all urged vaccine manufacturers to remove thimerosal from immunization products. Still, it remains a common component of many such shots. The vaccine makers could see a tsunami of lawsuits on the horizon.

OK, rewind your mental tape back to the months in the wake of Sept. 11 and the Bush administration's legitimate concern over smallpox -- perhaps the most hideous contagious disease faced by Americans in their two centuries-plus of existence. Intelligence agencies bombarded the White House almost daily with warnings that terrorists possess or will soon possess weaponized versions of this devastating disease that was supposedly conquered a quarter century ago. The White House and HHS quickly responded by beefing up stores of the very reactive smallpox vaccine and starting immunization of troops deploying to the Middle East and of "first responders" -- frontline emergency workers such as health care, public safety, law enforcement and other civilian professionals. About half a million in this category will get the smallpox shots.

Some powerful organizations are balking.

The Communications Workers of America sent Bush a letter last week complaining about "inadequate safeguards for workers in the program," including a lack of information about the risks of vaccination and no plan to monitor adverse effects or risk to family members who also will be exposed to the live virus from loved ones vaccinated. "Frontline workers in the fight against terrorism should not be required to shoulder the economic risk," wrote CWA president Morton Bahr.

No matter. The smallpox inoculation program of "frontline" responders rolls on. The government's smallpox shots initiative made sense to most Americans, and the White House wisely made general civilian reception of the shots, at least for the time being, voluntary. The Centers for Disease Control says about 42 of every million persons who receive smallpox inoculations will suffer severe side effects and maybe two out of every million will die. Those with suppressed immune systems and chronic illnesses will be even more vulnerable.

But lost in all the sky-is-falling publicity about threats of terrorism was a rider inserted into the recently-passed Homeland Security Act that protects pharmaceutical firms, hospitals, doctors and medical workers from liability for smallpox vaccine injuries and deaths.

This might seem logical. As defense policy analysts at the influential Cato Institute -- a Bush-favoring think tank in Washington -- explained, "The specter of liability claims clearly damages the incentive of manufacturers to produce new doses of the vaccine Š potential litigation risks reduce the incentive for pharmaceutical companies to produce vaccines in general and the smallpox vaccine in particular."

But the clause cleverly inserted into the Homeland Security Act also shielded vaccine makers from liability lawsuits for using components of vaccines, like mercury, that can cause brain damage and degradation of the immune system. Lawmakers on both sides of the aisle -- some of whom never noticed the shielding language -- are now promising to remove it.

They seem ready, however, to add the protective passages to new imminent legislation being pushed by pharmaceutical lobbyists -- total reform of the Vaccine Injury Compensation Program described above.

Vaccine safety advocates are howling.

Barbara Loe Fisher, president of the private sector National Vaccine Information Center -- the country's largest vaccine safety advocacy group -- calls the smallpox policy jammed into the Homeland Safety Act "heartless" since smallpox was thought eliminated from the planet and not even covered under the Vaccine Injury Compensation Program of 1986.

The Homeland Security Act, she says, "leaves the victims of a government-sponsored mass vaccination program without any recourse to either civil litigation or federal compensation for the vaccine injuries they sustain. It is wrong for the U.S. government to tell Americans to take the smallpox vaccine and then, when someone dies or is injured because of that policy, nobody takes responsibility."

Her organization is concerned "that the attitude the Department of Justice is taking toward smallpox vaccine victims is the same attitude that will prevail as Congress prepares to go back into the VICP (Vaccine Injury Compensation Program) to fix the many problems with it. Big drug company lobbyists and public health officials have always tried to discount the extent of vaccine injuries, and it is clear that an attempt will be made to shield drug companies from all liability while leaving most vaccine victims out in the cold."

The VICP was already inadequate under the tradition of American fairness.

Autism is a good example.

The average age of diagnosis for the onset of autism is 3.5 years. The VICP bill-drafters made sure the legislation preempted forgiving state and federal statutes of limitations for minors. Even the current VICP language imposes a strict three-year limit on claims from the date of injury, the vaccination itself -- not the date of discovery of injury, or recognition of causation, which is the language in much of tort law. Thus, victims of autism, by the time symptoms are evident and recognized, are already timed out -- as the lawyers put it -- from being considered for compensation from the federal compensation program. Going into court is their only option for redress if they think a vaccine caused their problem.

If the liability waivers are allowed to stand, or are incorporated into new VICP language, forget any evidence of causation. Existing lawsuits will be nullified and scores of thousands of autism sufferers will lose all chance of being heard under the vaunted American judicial system, no matter how good their cases.

So here we are in the turbulent wake of the chaos theory. A federal program that worked is weakened by big business erosion. Those ostensibly covered under it are further hammered by a new law hastily passed in the aftermath of terrorist acts. And to cure that defect in American liberty, Congress contemplates further gutting the original solution. Count on this: These chickens of childhood health policy will come home to roost. That little bottom-line butterfly may flap up a terrible storm of eventual deleterious health effects.

"Cutting off the threat of lawsuits," warns Fisher, "will cut off all incentive for the government and industry to make the compensation program work properly. It will remove the financial incentive for the drug companies to continually improve the safety of their vaccines. If you combine mandated vaccines with no liability and no accountability for anyone involved, it is a prescription for injustice and abuse of the public trust." Just the kind of chaos the big drug companies like.

John Hanchette, a professor of journalism at St. Bonaventure University, is a former editor of the Niagara Gazette and a Pulitzer Prize-winning national correspondent. He was a founding editor of USA Today and was recently named by Gannett as one of the Top 10 reporters of the past 25 years. He can be contacted via e-mail at Hanchette6@aol.com.

Wednesday, February 26, 2003 Niko Soursos of Richmond was born a perfectly healthy boy almost three years ago. He achieved every developmental milestone expected of normally developing children physically, neurologically and socially, says his father, Elias Soursos. But after receiving three mandatory shots of the hepatitis B vaccine by the time he was eight months old, Niko began displaying signs of neurological damage, becoming more distant, and losing language skills. Niko was diagnosed with autism last year after his second birthday. His father, a 35-year-old investment adviser with Canaccord Capital, began researching the possible causes of autism a few weeks after his son was diagnosed.

"Doctors used to say this is genetic," the Soursos said Tuesday. He now believes his son's neurological damage was caused by Thimerosal, an organic mercury compound used as a preservative in child vaccines. Two years ago, it was phased out for infant vaccines in Canada. It has also been phased out in the U.S. for infant vaccines.

Soursos says Thimerosal was used in hepatitis B vaccines his son received as part of Richmond's mandatory inoculation program for children. This week, Soursos was one of two parents who filed separate class-action lawsuits against several drug companies, claiming their sons suffered neurological damage after receiving vaccinations containing Thimerosal.

Soursos is suing drug companies Merck Frosst Canada and GlaxoSmithKline Inc., which made and distributed the vaccines. He is seeking damages for his son's autism therapy that costs $3,500 a month, part of which is covered by a $1,600-a-month government grant.

His lawsuit claims the drug companies failed to warn of the risks associated with Thimerosal in vaccines. "The defendants failed to communicate the dangerous nature of the vaccines to the public and must be held accountable for their negligence," Vancouver lawyer David Klein said Tuesday.

Klein is representing the Soursos and the plaintiff in the other class-action lawsuit, Jaqueline Chamberlain of Sooke, whose 10-year-old son Aaron also suffers from autism. "It may be too late for Aaron and Niko but Thimerosal has been taken out of all routine vaccines for infants in Canada," Klein said.

The lawsuits claim the drug companies should have known of the neurotoxic effects of the mercury contained in Thimerosal, which had been used as a preservative and anti-biological agent since the 1930s. "Mercury is one of the most toxic elements on earth," the lawsuits claim. "Mercury poisoning is well documented in medical literature." Infants are more susceptible than adults to the toxic effects of mercury because mercury interferes with infants' developing neurological systems, the lawsuits say. The lawsuits allege that the drug companies developed, tested, manufactured, licensed, distributed, marketed, supplied and/or sold the vaccines with the knowledge that they would be injected into infants.

Chamberlain's lawsuit claims her infant son Aaron suffered neurological damage after receiving two doses of the DPT vaccine containing Thimerosal, which is manufactured by Aventis Pasteur Limited. The DPT vaccine, which was phased out in 1994, was used against diphtheria, whole cell Pertussis (whooping cough) and tetanus. Like Niko, Aaron was born perfectly healthy and demonstrated social, language, cognitive, behavioural and physical skills appropriate for his age, the lawsuit says.

But before his second birthday, after receiving the DPT vaccine, he became unresponsive, withdrawn, slow in speech development, developed repetitive behaviours and an obsessive-compulsive disorder. Aaron was diagnosed with autism at age five. He still has limited language and social skills, the legal action claims.

By Sara Waliis And Rebecca Baxter , The Evening Chronicle Six Tyneside families are taking legal action over claims the controversial MMR vaccine seriously injured their children. Lynne Forster, of Buttermere Gardens, Low Fell, in Gateshead, has joined the growing group of claimants from across the country after her son Sam fell ill following the triple vaccine.

Young Sam was given the MMR jab on September 5, 1999 and has suffered undisclosed injuries as a result. A writ issued at London's High Court by Ms Forster last week claims damages against drugs company Merck and Co Inc. She is seeking damages of more than £50,000 for the injuries said to have been caused by the MMR vaccine.

The controversial Mumps, Measles and Rubella vaccine has sparked a massive surge in law suits to claim damages for serious injury. Hundreds of parents across the country have launched claims against drugs firms. They say many children involved in claims now in the pipe-line have suffered blindness, brain damage and other serious problems after being vaccinated.

Mum-of-one Debbie Cole, of Crofter Close, Annitsford, today told how she was right behind parents' decisions to take their cases through the courts. Mrs Cole, who has a two-year-old daughter, Jennifer, was responsible for setting up the first single jab clinic in the North East. She said: "When I got involved with the single jab unit I had several calls from parents who were adamant that the MMR had badly affected their first child and were desperate not to take the risk with their second. "It was heartbreaking. One parent told me that her child was perfectly all right until they had the MMR injection. After that, the child had to be hospitalised after running a high temperature.

"These parents are going to court because they feel the need to get to the bottom of what has caused their child's problems. They are convinced it was down to the MMR. A lot of these children will need long term care and any compensation money would help them with that. "I don't think there has been enough research in to MMR. The Government seems so focused on getting parents to have their child vaccinated with it, but they are not listening to people's concerns." Battling Mrs Forster is just one of a growing number of parents claiming their children were given defective vaccines.

No date has yet been fixed for the Forster's court hearing where they will be represented by solicitors Hodge Jones and Allen. All six families, including the Forsters, are members of the JABS (Justice, Awareness and Basic Support) Group which is a support group for vaccine-damaged kids.

JABS has called on the Government to suspend the current MMR vaccination programme in favour of the administration of three separate vaccines for Measles, Mumps and Rubella to be offered at a time interval and age that is appropriate. In excess of 900 families from around the UK have contacted the JABS group to report serious health problems following the MMR vaccination.

Pennsylvania received 22,500 doses of the smallpox vaccine from the federal government as part of a voluntary vaccination campaign targeting 450,000 people nationwide, but the state has only given 57 doses of the vaccine so far. Most of Philadelphia's hospitals have said they do not intend to vaccinate until evidence of a smallpox outbreak is seen in the United States, and District 1199P of the Service Employees International Union, the state's largest health-care union, cautioned its members not to be vaccinated until there are better protections in place for healthcare workers and patients. The government is considering offering $262,100 for each person who dies or is permanently disabled by the vaccine. The proposal would cost up to $30 million and needs Congressional approval.

A Senate committee Wednesday abruptly dropped plans to move legislation nullifying hundreds of lawsuits claiming injury from childhood vaccines, raising questions about whether a bipartisan deal to move the bill was unraveling. Sen. Judd Gregg, R-N.H., chairman of the Senate Health, Education, Labor and Pensions Committee, said action was being postponed because events in Iraq had pulled away Senate Majority Leader Bill Frist, a committeemember and the bill's prime sponsor.

But Democrats said the postponement had more to do with objections lodged at the last minute by two of the four major manufacturers of vaccines. Sen. Christopher Dodd, D-Conn., who led negotiations for Democrats, said he was disappointed that the committee action was being postponed until after the upcoming Easter break. "We have worked very hard to work out a compromise to the satisfaction of almost everyone here," Dodd said. "There may be some misunderstanding about what some of the provisions of the bill do." Under the legislation, more than 200 lawsuits filed by families who believe their children were injured by vaccines would be sent instead to a special federal fund. Senators led by Frist say these cases always were intended for the Vaccine Injury Compensation Program, but lawyers had found a way to skirt the system.

The issue became contentious late last year when Republicans quietly slipped the change at the last minute into homeland security legislation. Under pressure, lawmakers undid the move in subsequent legislation, but vowed to try again this year using standard legislative procedures. Childhood vaccines are safe for almost all children, but a small number are injured each year. Under current law, injured families must file claims first with the compensation fund, where cases are independently evaluated, before going to court. Average awards are just under $1 million. If someone's claim is denied, or if the monetary award is considered unsatisfactory, a lawsuit may be filed in federal or state courts. Some families have found a way to skip the compensation fund and go directly to court by claiming their children were harmed by a vaccine's ingredients, rather than by the vaccine itself. Specifically, many contend their children's autism is caused by a preservative called thimerosal, which contains mercury and once was used in the measles-mumps-rubella vaccine. The Institute of Medicine, which gives expert advice to Congress, reviewed the issue and said in 2001 it found no proof that autism is caused by the MMR vaccine or by thimerosal. The report did say a link between thimerosal and an increased risk of neurodevelopmental disorders is medically plausible.

In any case, Frist, a physician, argues that these cases should have gone through the compensation fund first, like other vaccine-related claims. He said there are only two vaccine manufacturers in the United States and just four worldwide because vaccines produce so little profit. The threat of lawsuits will drive even more companies out of the business, he argued. The bill improves the fund for families filing claims in several ways. It would increase maximum amounts available for pain and suffering from $250,000 to $350,000, increase the statute of limitations for filing claims from three years to six years after the onset of the injury and, for the first time, allow parents to file independent claims based on their children's suffering.

Under the deal reached late Tuesday with Dodd, Republicans agreed to give families a one-year window to enter the fund, even if they are outside the new, six-year deadline for filing claims. That includes those with court claims pending and those who never filed a case with a court or the fund. A Democratic aide, who asked not to be identified, said that Merck and Wyeth, two of the four major vaccine manufacturers, opposed the compromise as being too generous to families. They wanted a stricter statute of limitations. The aide added that lobbyists for vaccine manufacturer Aventis and pharmaceutical giant Eli Lilly supported the compromise. Lilly is the manufacturer of thimerosal and is facing several lawsuits that would be moved to the fund under this bill. The Vaccine Injury Compensation Program is financed by a 75-cent fee on each childhood vaccine administered. Copyright 2003 The Associated Press. All rights reserved.

GOVERNMENT & MEDICINE

Frist bill further safeguards doctors from vaccine lawsuits The legislation also would enhance the rights of children injured by vaccines. By Joel B. Finkelstein, AMNews staff. April 28, 2003.

Washington -- Proposed reforms to the Vaccine Injury Compensation Program would close a loophole in what was supposed to be a no-fault law to protect physicians and vaccine manufacturers from lawsuits.Physician groups credit the VICP with helping to turn around national immunization efforts that were beleaguered by vaccine shortages. Before the compensation program began, vaccine manufacturers complained that unfounded lawsuits were too costly, and physicians were worried about getting sued for administering mandated vaccines.

The 1986 law that created the program mandated that families of children with potentially vaccine-related disorders apply for compensation before filing a lawsuit. As a result, the number of vaccine-related lawsuits dropped dramatically. "The program has been outstanding," said E. Stephen Edwards, MD, American Assn. of Pediatrics president. "It made a huge difference, having these liability protections."

But lawyers eventually found a loophole in the law that enabled them to sue when vaccines containing thimerasol were involved. They argued that it was not the vaccine that caused the problem, but the mercury-containing preservative, which was not explicitly covered under the law. Lawsuits for vaccine injuries dropped dramatically after the Vaccine Injury Compensation Program was formed in 1986. Senate Majority Leader Bill Frist, MD (R, Tenn.), has introduced a bill that, as part of overall reform of the compensation program, addresses this issue by clarifying that the law applies to the individual ingredients of vaccines.

Similar provisions in the 2003 budget package were ultimately repealed under pressure from Democrats who complained that it would interfere with pending class-action lawsuits. Dr. Frist is working to forge a compromise with Democrats. "Vaccine shortages threaten our children and the health of our nation, yet unnecessary litigation continues to destabilize our vaccine supply by causing fewer vaccines to be developed and produced," he said.

Preserving children's rights The bill also addresses issues raised by parents who say the program does not cover enough children. For example, it would extend the statute of limitations for vaccine injuries from three to six years.

"This will preserve the right of as many children as possible to participate in the program," said Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, a parent-led organization that advocates for reforming the mass vaccination system. Under the new bill, the statute of limitations for vaccine injuries would be extended from 3 to 6 years. The bill would make congressional oversight more active, with reports due to Congress every six months. The center has called for this measure because it believes some Health and Human Services decisions attack the intent of the original law.

During the 1990s, HHS made substantial changes to the list of illnesses that could be presumed to be related to vaccination if no other cause was determined. Among these changes, HHS removed seizure disorders from the table and redefined encephalopathy in such a way as to also remove it from included disorders.

"We were promised it wouldn't be like this," Fisher said. The center hopes that better follow-up by Congress would help the program more closely follow the intent of the law.

Before the program was created, parents were faced with the choice of pursuing expensive court battles or settling out of court for what were often small amounts, Fisher said. In contrast, the program compensates families on average $800,000 to $900,000. But Fisher said HHS rejects three out of four compensation requests.

Policy vs. science According to Fisher, the program was developed as a political solution to a scientific problem.

In the absence of convincing research on the causal relationship between vaccines and certain disorders that may develop during childhood, the no-fault program would ensure that a family would have quick and easy access to the compensation that it needed to care for a sick child.

$800,000 to $900,000 is the average compensation families receive from the VICP. The parents of children injured by vaccines, who were involved in negotiating the terms of the original law, were told that the program was meant to provide an alternative to going to court. Congress recognized that this would mean making a presumption of causation in the families' favor, even if this resulted in some children being compensated who were not, in fact, injured by a vaccine.

The AAP's Dr. Edwards said that the compensation should be based on science. He pointed to the lawsuits based on thimerasol, which has only anecdotally been linked to the development of autism. Now that most vaccine manufacturers have eliminated the preservative from their vaccine products, "we're going to have the biggest natural experiment ever conducted," Dr. Edwards said.

Dr. Frist's bill provides for HHS-administered grants to study the associations between vaccines and childhood disorders.

Autism Epidemic Hitting Children and Families From All Sides Is Autism Community Defenseless? Not Quite.

Let's list those "sides."

* IDEA, the Federal legislation protecting the rights of disabled children to a meaningful education tailored to their disabilities is on the verge of being gutted. 6.6 million students with disabilities and their families stand to lose their right to a free, appropriate public education. H.R. 1350, passed by the U.S. House of Representatives on April 30, 2003, reauthorizes the Individuals with Disabilities Education Act (IDEA). If a similar bill passes the Senate millions of students with autism and other disabilities will most certainly be left behind.

* The Vaccine Injury Compensation Program, also currently up for revision, is arguably one of the most egregious violations of the US Constitution Fifth Amendment that states: " . . .[citizens shall not] be deprived of life, liberty, or property, without due process of law; nor shall private property be taken for public use, without just compensation." [See article above, "Senate GOP Backs Away From Plan To Extend VICP Statute Of Limitations."] How is it that the government is not confiscating the private property that is the financial compensation of vaccine-damaged citizens, without just compensation and without due process? This refers to the arbitrary cut-off date for claims and the arbitrary caps put on damage awards. (Add to this, the gross negligence in indemnifying the vaccine manufacturers against lawsuits. see next item). Why is VICA not an abortion of justice prima facia? There is a segment of the community that believes VICA cannot be reformed and must be scrapped altogether. If the vaccines are not clean enough to need special protective legislation against due process, they are not clean enough to go into our children's bodies. We can make clean vaccines. Yet, so-called compromise proposed legislation threatens to confiscate the due process and due damages of all children whose parents did not discover the cause of their child's damage within the proposed six-year limit.

* Government and Pharmco collusion fires up the epidemic. There is growing evidence that vaccines may indeed be the source of the autism epidemic. Government legislation giving vaccine makers carte blanc protection against law suits has lead to poorly tested, and poorly regulated vaccines. Those in Washington who are supposed to regulate vaccines have a revolving door relationship with the pharmaceutical companies they are supposed to be regulating. Often bureaucrat-scientists go to work at very handsome compensation for the companies they "regulated" before leaving public service. These sweetheart deals and dirty vaccines, if the connection to autism bears out, threaten the public health and indeed the field of public health itself. These defenders of the status quo who resist relevant research and claim there is no real increase in autism, only better diagnosis, are growing the autism epidemic in their attempts to sow complacency. As the prevalence numbers continue to increase as a result, there is that many fewer dollars available to each autistic and disabled person/child, increasing the resource squeeze on all sides.

* State Budget Cutbacks in Disability Services. Many state budgets, especially California with its huge autism population, are deeply in the red. Everything from respite care to in-home support services to supported life assistance is on the chopping block. In California there is a $36 Billion deficit due to legislative mismanagement, quasi-corruption and inept gubernatorial leadership. There is a recall campaign to oust the governor. But he's only the scab on top of a political infection that has been growing for years. At least a dozen other states face the same music.

* Lack of political representation. The autism community stands almost naked against these forces. There is no national political organization to represent the interests of the autism community. While there are high-profile national societal and research groups who do address some of these issues, like joining in on campaigns to defend the IDEA, they are set up to mainly perform social services and functions, research, support and educational functions. National non-profit groups so set up are severely restricted in the kinds of political activities they can perform. Typically they don't have the skills or backbone for grass roots political organizing and lobbying. There is a vacuum.

The main problem is that the autism community, for a community of its size, is too big, too new. Our numbers have grown so rapidly over such a relatively short period of time that we simply have not had the time (and often the energy) to build up political infrastructures. These are made up of alliances and coalitions between the smaller, local groups into larger statewide and even national groups to defend ourselves, our children. There is a United Cerebral Palsy for example, but you ain't gonna find no United Autism anytime soon enough for what's goin' down now. So what political assets does the autism community have, given this scenario?

* Independent local parent groups and ASA Chapters. There are about 200 ASA Chapters across the US, and about as many independent groups like FEAT in Northern California and TACA in Southern California, as well. In California, about 30 Independent groups and ASA Chapters have joined together into the California Autism Coalition (CAC). CAC is scrambling to create an organized response against the Budget Monster trying to Devour California's autistic and disabled community. The group lacks seasoned grass roots political organizers and that makes it all the more of a challenge. But there is the start of a "there" there. It is a possible model for other states to follow, if they haven't already.

* We have the Internet. And it came just in time, too. The connectivity of the Internet, along with the easy retrieval of information, can accelerate the political process. Email discussion/support groups are new things. Google is new. Online newsletters are new. Emailing your congresspersons is new. Websites are new. And yes, not-the-lunchmeat spam is new, too. Families coming online to autism and the Internet are learning new things about both, from behaviorism to blogs, and mostly from other parents. (Don’t know what a blog is? Just type the word into Google and you'll find more than you ever wanted to know about it. Don’t know what a Google is. . .?) Pre 1997 if you wanted to reach all the autism families in your local area, you had to set up a phone tree and have volunteers take a chunk of the list – assuming you had a list -- and call, and call, and call. Now, everyone – with Internet access - can be subscribed to a local email list and with one email, everyone gets informed. Does anyone dispute that for effective autism advocacy for your family, Internet access is a must? But the 'net seems to have devolved mostly into a shopping tool and a note mailing device. I believe we have yet to really take advantage of this medium for political purposes.

* We have us. Or more specifically, we have the autism phenotype that is of many of us. The genetic component of autism that brings us its grief, also brings us the creativity, intelligence and the perseverance associated with its upside. We created, made and have the hardware, the software and the human-ware. Autism is a mechanical problem. Autism solves mechanical problems. Within the fruit of autism is the seed of its cure. God willing, may it flower forth soon.

Hundreds of thousands of people nationwide who received the Lyme disease vaccine have received what lawyers labeled an impressive settlement. But if you are one of the recipients of Lymerix shots, don't bother looking for a check in the mail. The benefits from an agreement finalized last week with the vaccine's manufacturer, SmithKline Beecham Corp., now GlaxoSmithKline P.L.C., are not monetary - unless you are one of the plaintiffs' attorneys, who will split more than $1 million.

Stephen A. Sheller, a Philadelphia lawyer involved in the half dozen class-action lawsuits filed in New York, New Jersey and Pennsylvania, said the case was never about "putting hundreds of millions of dollars" in plaintiffs' pockets, it was about public safety.

"Our goal was to warn the public about the vaccine," Sheller said.

The cases were consolidated in Chester County because so many people had received the vaccine there, Sheller said. The plaintiffs were identified as "all individuals who have been administered the Lyme disease vaccine, commonly known as Lymerix." Sheller said the impetus for the suits, filed in 1999 and 2000, came from worried doctors. "The doctors are the heroes here," Sheller said, adding that the suits' primary objective was to obtain warning labels about the vaccine's possible side effects.

But Glaxo withdrew the vaccine from the market in February 2002, making that goal moot. At the time, a company spokeswoman said hundreds of thousands were vaccinated in 1999, and only 10,000 were expected to get the shots in 2002, too few to cover the manufacturing and marketing costs. "We discontinued the product for commercial reasons, not because of the litigation," Danielle Halstrom, Glaxo's director of product communications, said.

Halstrom called the allegations about the vaccine's side effects "scientifically unfounded" and said Glaxo executives stand by the the drug's safety. She said the company's attorney was unavailable for comment on the settlement. Sheller said tests have shown that the genetic makeup of 25 to 30 percent of the population makes them susceptible to treatment-resistant arthritis if they receive the vaccine, a finding disputed by the Centers for Disease Control.

More than 500 vaccine recipients have reported complications, Sheller said. The settlement does not prevent those people from pursuing personal-injury suits against Glaxo, he said, adding that many are pending. Sheller said the settlement award - attorneys' fees of $926,250 and costs of $137,997 - was not an easy sell for Chester County Judge Jacqueline C. Cody, who presided over the case.

"Judge Cody was right for scrutinizing the settlement," Sheller said. "She was protecting the interests of the public." In a footnote to the settlement order, Cody said she had "unanswered concerns regarding the size of the award of counsel fees in relation to the outcome of the litigation." In addition, she questioned the efficiency of "having 34 professionals handle a single case." Cody, who had reduced the award by five percent before approving it, said her concerns were not allayed when a truck appeared at the courthouse loading dock on May 31, filled with the plaintiffs' files. Sheller said he wanted to make sure the judge knew how much work had gone into the case.

"The wasteful expense of such a grandstanding gesture is precisely the type of abuse that casts doubt on the documented hours and expenses of dedicated professionals of high integrity," Cody wrote. Sheller said the truck didn't cost a dime because the delivery was late. The plaintiffs named in the suit could not be reached for comment. Lyme disease, which was named after the Connecticut town where it was discovered in the 1970s, is transmitted mainly by deer ticks. It creates symptoms that include fatigue, headaches, and joint pain. Lyme disease can be treated with antibiotics. Untreated, it can cause serious medical problems, including arthritis, facial palsy and encephalitis.

In 1999, 16,273 cases of Lyme disease were reported to the CDC. Ninety-two percent of these were from the states of Connecticut, Rhode Island, New York, Pennsylvania, Delaware, New Jersey, Maryland, Massachusetts, and Wisconsin.

From Michael Belkin

http://www.ananova.com/news/story/sm_818362.html

'MMR disabled' lose legal aid

Hundreds of severely disabled people allegedly damaged by the MMR vaccine will no longer receive legal aid in their bids to win compensation, their lawyers say. More than 1,000 claimants are currently involved in litigation against the makers of three brands of the controversial measles, mumps and rubella triple jab.

Many are severely disabled and the majority have been receiving public funding for their legal action, which is due in court in April 2004, solicitors Alexander Harris said. But the Legal Services Commission (LSC), which provides legal aid, has decided to withdraw funding for the MMR cases from September 29 after reviewing the situation, the solicitors said. All the claimants who have been given legal aid will stop receiving the funding from this date, a spokeswoman for the lawyers confirmed. Alexander Harris said it was in the process of appealing the LSC's decision.

A Funding Review Committee of independent lawyers will hear the appeal on September 30. The committee's decision will be binding on the LSC. A spokeswoman for the LSC said the organisation was not able to comment further or give reasons for its decision to withdraw the funding until after the hearing. Currently, people classed as being 60% disabled through vaccination are eligible for a one-off payment of £100,000 from the Government's Vaccine Damage Payment scheme.

But campaigners argue that this is barely enough money to pay for even one year's care of a severely disabled child.

$150,000 DPT Vaccination Settlement The U.S. Court of Claims approved this settlement for the estate of an infant who died three hours after the administration of a Diphtheria Pertussis Tetanus Vaccination. The firm obtained this compensation under the Childhood Vaccination Injury Compensation Act, which provides for a maximum of $250,000 in a death case. This settlement was particularly noteworthy because the infant had other significant medical problems, which could have arguably contributed to the cause of death.

$40 Million Vaccine Structured Award The parties to a National Vaccine Compensation Claim today agreed not to seek a review and to accept a decision, dated March 31, 2000, by Special Master Laura Millman of the United States Court of Federal Claims. The decision awards a life-care plan, which will pay $40 Million to a Brooklyn girl who requires constant medical attention for her developmental disabilities and seizures that resulted from a whole-cell DTP vaccination. Britcher, Leone & Roth, LLC successfully prosecuted this case involving complex medical issues. The plan will provide in excess of $8 million in present value benefits and $40 million in payments, if the child lives to age 76. $19 Million Vaccine Structured Award A Paterson girl suffered retardation, seizures and behavioral disorders from a rubella vaccine. Our firm alleged that the vaccine, which led to her being stricken with encephalopathy, caused her disabilities. The $19 million total payments to be received are based on the girl's life expectancy of age 75.

I am one of those parents and have seen enough evidence to convince me thimerosal was a factor. What is unsafe about thimerosal is that it is mercury and the levels that were found in my son at five years old after his MMR shots were unsafe. He was administered three sets of MMR shots on the same day. All these shots have been mandated by the government in order to serve the public good. I am 37 years old and the number of shots I received by the time I was eight years old was 12 shots now with the advent of mass daycare all kids need 40 similar shots by the same age of eight.

I hate lawyers and mass lawsuits. I don't want a handout and home school my kids because I refuse to send my kids to government schools. However, I cannot get a nickel out of the restrictive VICP to help me cover over $125,000 in actual therapy costs.

I am proud of my son, my wife, my family and my son will probably be well enough to attend college because our faith continues to support and strengthen us through the autism journey. But the last thing I want is more government solutions. What the parents of autism children need is money to help them find their own medical and therapy solutions to answer the puzzle we call autism.

ALMOST 150 sets of Irish parents who claim that their children developed autism after receiving the measles, mumps and rubella (MMR) vaccine, are suing the manufacturers of the jab, writes Dearbhail McDonald. Lavelle Coleman, a Dublin law firm, has notified five drug companies of its intention to sue on behalf of a “significant group of Irish families”. The letters, which were received in the past fortnight, state that the parents will claim that the MMR vaccine caused their children to “develop a new form of regressive autism and associated bowel disorder (autistic enterocolitis)”.

The Irish families are likely to have to rely on the controversial research by Andrew Wakefield, purporting to establish a link between the triple jab and autism, a brain condition. In Ireland, legal notices have been issued to GlaxoSmithKline subsidiaries, Merck Sharp & Dohme and Aventis Pasteur MSD, which were paid by the government to manufacture and supply the MMR vaccine. It is believed the Department of Health, which administers Ireland’s vaccine programme, will be named as a co-defendant in the multi-million-euro action.

The parents are also demanding a full tribunal into vaccine-related injuries in children. “There is something wrong. There are too many Irish families telling the same story,” said Cecelia Young, whose 14-month-old son Adam lapsed into a coma days after receiving the MMR vaccine. Last week, Richard Stubbins, managing director of Aventis Pasteur MSD in Britain and Ireland, said the company would “vigorously defend” any action taken in the Irish courts.

http://www.theherald.co.uk/news/16110.html The Herald, UK

Families in autism link claims fear legal 'threat'

DAMIEN HENDERSON

May 14 2004 SCOTTISH families claiming the MMR triple vaccine has caused autism in their children have accused Merck, the pharmaceutical giant, of trying to intimidate them into dropping compensation claims. The company has given claimants until today to abandon legal action or face potentially crippling costs. The move comes after legal aid worth £10m was refused last year.

A letter sent to more than 500 families on April 29 by Lovells, Merck's solicitor, asked the families if they wished to continue the action. It warns that, after legal aid is withdrawn, they will be "at risk of facing a liability for any further costs Merck continues to incur in defending the claim" unless an undertaking is given "not to issue any further proceedings arising out of vaccination with the MMR vaccine against Merck in this or any other jurisdiction".

The letter provoked a furious reaction among families, which say the discontinuance notice provided by Lovells would prevent a claim being made in the future should any firm evidence emerge to support the disputed link between MMR and autism. Anne Glowacki, of Dunipace, Stirlingshire, whose daughter Ashleigh, 12, is autistic, said she and her husband had no choice but to abandon their legal action, adding: "I thought they were trying to threaten me. We want to fight the case but it would be our house that we lose. We don't have the money they have."

Jackie Fletcher, national co-ordinator of Jabs, a charity supporting families who believe their children have been damaged by vaccines, said parents had been caused "a great deal of distress" by the threat of legal costs. A spokeswoman for Lovells said its offer was intended to inform claimants of the risks of continuing legal action and was not meant to be intimidatory.

MMR Killed My Daughter Daily Mail (UK) 18/5/04 by Bonnie Estridge

Last week the parents of 1,000 children allegedly damaged by the MMR vaccine were sent letters by one of the drugs' manufacturers threatening them with huge legal costs if they refused to drop their claims for compensation. One mother, Carol Buxton, found the news particularly shocking. Thirteen years ago her daughter fell ill and died following the MMR jab but Carol, a travel consultant who lives with her police officer husband Tony and three sons in Northampton, DID get her day in court - with astonishing conclusions. Here she reveals how she made the Government accept liability.

When I heard of this latest twist in the MMR debacle, my blood ran cold. Why should these parents be intimidated into dropping their claims for compensation? If anyone should believe that they are right to fight on, its's me. For not only did my daughter fall ill after she was injected with the triple jab, she died as a direct result of it.

How can I be so sure? Because I was paid £85,000 in compensation for her death by the Government.

The decision that MMR led to my only daughter's death was confirmed by doctors and agreed at a tribunal. So what I want to know is: why did the the Government admit liability to me when it is villifying so many others?

I will never forget the moment I opened the door of Hannah's nursery on a winter's night 13 years ago. The room was warm but I felt a chill throughout my body - I sensed something was wrong. I looked into the cot and froze. My baby had died in her sleep - it was just 2 months before her third birthday. I felt shock, panic and a stabbing emptiness as well as anguish. Hannah had died from one of the hundreds of fits she suffered during her short life. My husband Tony and our three sons were devastated. The Department of Health was forced to listen to me and two other families whose children also died, when we brought our case.

But it was only after her death that they paid compensation, admitting that the brain damage she suffered was directly attributed to MMR. So what price do today's parents have to pay before anyone will listen? We didn't go to court because our daughter died. We had been trying for compensation for some time before because Hannah was very disabled and we wanted her to have some kind of financial security. She was suffering up to 40 fits a day but we were told that it would take months or years before a decision could be made. But 2 years after she died our case was heard and the link between her illness and MMR was agreed. Our nightmare began when Hannah was 18 months old in October 1988. She had been due to have the single measles vaccine at 13 months but had a cold so our GP and I decided it should not be given.

I had no misgivings about my baby having the single measles vaccine as my sons, now in their 20s, had all had it with no ill effects. As we had already booked a holiday we would have been away at the time of the next available appointment. Unfortunately the third time Hannah was called to be vaccinated was the first week the MMR jab was introduced. I thought nothing of it at all. It seemed a good idea to get everything over in one go. She was fine after it - but a week later, she developed a very high temperature and became very red in the face. I called the doctor out and asked him whether he thought there was any link with the vaccine but he said this was highly unlikely and diagnosed her as having 'slapface syndrome' - a mild virus which causes a high temperature and a marked redness of the face.

I gave her some Calpol to try to bring her temperature down and put her to bed. When I went to tuck the boys up, all was quiet in Hannah's nursery. But as I opened the door to look in on her, I could hear a strange noise. I froze - she was having convulsions and her eyes were staring and glazed. I stripped her clothes off and made sure she couldn't bang her head on the side of the cot, then called the doctor. He arrived minutes later. He looked alarmed because she wasn't calming down at all and suggested I take her to the hospital which would be quicker than calling an ambulance.

A neighbour drove us there and when we arrived Hannah was rushed away for tests. It took almost four hours to stop the fits, then, heavily sedated, she stayed in intensive care for a week. I mentioned the MMR but I certainly didn't make a fuss about it because I could see they were more concerned with what was happening at the moment: they had to stop Hannah having these fits.

The doctors said they didn't think the vaccine had caused it. They explained that it was quite common for babies to have febrile convulsions when they had a high temperature due to a virus. There was no mention of the fact that she might be brain-damaged. Tony and I were terrified when we took her home because she was just not right. She was jittery - having always been calm - and had stopped talking. I felt very frightened that she would have more fits, although she'd been put on medication to prevent them. Two weeks later the fits started again. When a brain scan showed nothing, Tony and I embarked on a treadmill of hospital visits, including to Great Ormond Street, in an effort to find out what was causing them.

Blanks were drawn everywhere we went. Epilepsy was suggested but there was no family history of it or anything on the brain - such as a tumour - to indicate why she might have become epileptic. By then, Hannah was having anything from one to 40 fits a day of varying intensity. Looking back, I don't know how I coped. I had the three boys to look after too and we tried to make family life normal. But how could it be? I never felt safe to leave Hannah for a minute. It was so stressful to see her suffer. Hannah was definitely not normal; she had been slow in walking even before having the MMR jab but I was told that some children take awhile to catch up and by the time she was two, she'd be fine. Now she was frankly backward. She had virtually stopped talking - the only word she ever said now was 'Mummy' which broke my heart whenever she said it and she always had an unfocused look in her eyes.

She was never diagnosed as autistic but I wouldn't be surprised if this was the case. Over the 18 months that we tried to find out what was wrong with Hannah I could see the doctors were bewildered. I did not mistrust any of them even when I found out that a strain of the MMR being used in this country had already been banned in Canada. I truly felt that the doctors were unaware of this but in hindsight I'm not completely sure they were. As it turned out the MMR vaccination was banned in Japan in 1992 and that country went back to single vaccines from then on. The day Hannah died everything had been perfect. We'd visited my sister-in-law who had just had a baby and Hannah seemed to be enjoying herself. That night I went to look in on her and found her dead in her cot. She'd had a fit in her sleep.

Before Hannah died, Tony and I had been terribly worried about how we would look after her as she got older. We are a comfortably off family, though not wealthy by any means and we thought Hannah would need very special care as she got older. We didn't know how we would be able to afford it while also giving our other children a reasonable standard of living. During Hannah's illness I always felt there was a connection with the MMR vaccine but my opinion was either dismissed by doctors or they genuinely appeared not to know. Then I heard about the Vaccine Damage Unit, a body set up by the Government to look into any case where a person might have been injured by a vaccine. Tony and I decided we would apply for compensation, which would perhaps help us to look after Hannah.

Every so often I received letters from the Unit saying the matter was still being looked into. But two weeks before Hannah died, I had a letter saying her case was on-going and would probably take months or years to reach a conclusion. Just after she died, I had another letter saying that the MMR link was unproven and I became very angry. I believed that they wanted to get rid of this 'problem'. So we went to appeal, deciding to represent ourselves. We went to the tribunal in March 1992. There had been an autopsy, as this had been a case of sudden death but no conclusions had been drawn from it. There were half a dozen people on the tribunal, a mix of lay people and doctors.

I was questioned thoroughly for an hour and a half then they said I would be informed whether I would be awarded compensation by post, as all the facts now had to be carefully considered. Four months later we received a letter which included the following: 'Hannah Buxton was disabled as a result of a vaccination to which the claim relates'. It also stated: 'The tribunal found it particularly significant that the reaction to the MMR vaccination was exactly at the expected period of time following this vaccination.'

'This reaction was severe and prolonged and therefore the development and progress were halted and if anything, deteriorated to a marked and obvious extent. We note this evidence is uncontested and to our minds argues strongly in favour of the award.' In other words the Government had not argued against the case and were admitting liability. We were awarded £20,000 - the maximum amount allowed at the time; this was followed by another £65,000 four months later because the original payment was deemed not to be enough.

I really didn't want to know about the money. I just needed to know why Hannah had become so ill and why she had died. The most important thing for me was that someone had confirmed what I had always suspected - that the MMR jab had caused this; that MMR had done so much damage to her brain that she became severely handicapped and started having fits. That is why I am so angry that the parents who believe MMR has damaged their children are not being listened to. I have heard that a number of those autistic children also have fits. I cannot imagine what it must be like caring for these children and I have the utmost respect and admiration for those who do. They must be listened to, given answers and helped.

Does a child have to die before it its acknowledged to have been damaged by MMR? Is it not enough that so many parents have a disabled child to look After? Of course, not every child is damaged by the MMR jab. But if there is any doubt, then that case should be investigated individually - the parents should not simply be fobbed off as a group because they are fighting together. There should be a tribunal for each and every one of them to prove or disprove that there is a link between their child's illness and MMR. Someone needs to come clean about MMR as this problem goes on and on. Our children are geting pushed into having this vaccination and doctors should listen to parents when they say they are afraid of what might happen.

The Govenment should not deny parents the option of the single measles vaccine. Hannah was my precious only girl and barely more than a baby when she died. Now I want today's children to have a better chance. There must be a proper investigation into MMR - drug companies which are paying doctors to conduct their own research surely cannot give unbiased answers. Vaccine damage is known and recognised. Last year more than 1,000 Japanese children were awarded compensation after being damaged by MMR vaccination. Those families had been battling for more than 10 years to have their day in court.

Why can't parents in this country be given the chance to be heard - and taken seriously - now?

In regards to Devon & Natalie Corzine's case filed in National Vaccine Injury Compensation Program regarding the death of their infant daughter, Sarah, from a hypoxic seizure following administration of DTaP, HIB, IPV & Rotavirus Vaccine, April 21, 1999 at 2 months of age (but was premature 2 months weighing 3#, 3oz at birth & receiving hep b vax at birth even though 2 months premature!!!!!!) Criminal.

Ruling posted today at http://www.uscfc.uscourts.gov/osm2004.htm

It was filed on April 23. Read towards the end what Special Master French says about SIDS - it's more than they could have hoped for

I want to tell you that our lawyer informed us that the Federal Agency in Germany which is responsible for paying lifelong pensions after injuries caused by vaccines WILL ACCEPT VACCINATION DAMAGE AFTER HEPATITIS A/B in my son and will pay him a lifelong pension. We are just waiting for the final verdict and the degree of payment. But it is accepted !!!!!!! I thank especially Dr. Jerry Kartzinell, Dr. B. Merizalde, Dr. Anthony Bazzan and all the doctors who helped to write support letters. Special thank to Dr. Mark Geier and David Geier who gave us support sending us their research which we had to translate into German. In pour case the thiomersal came with the DPT shots and the Hepatitis had all the aluminum which brought my child into autism. This is the first lawsuit in Germany and we fought 4 years ! And now there will be more and this will make big noise as autism is terribly on the rise in Germany. I also have a lawsuit running against the pediatrician and here I am in a real battle with experts paid by the pharmaceuticals but fortunately the judges are pretty good.

Thank you all for your prayers , help and support ! The universal laws always work ! This all will come up ! Tina Metz

BY BILL DOLAN Times Staff Writer LAKE STATION -- Cathy Price hasn't danced in years. She hasn't roller-skated, gone to a movie or stood on her feet, either. Next month with be the 13th anniversary since she woke up numb from the waist down, her body ravaged by poliovirus contained within a vaccine that went wild and infected her.

The 47-year-old Lake Station woman and her husband, Charles, are now fighting to collect $5 million from the vaccine's manufacturer, American Cyanamid Co., now known as Wyeth Holdings Corp. The New Jersey-based pharmaceutical company filed motions recently in Lake Circuit Court in Crown Point and U.S. District Court in Hammond to overturn a judgment that the firm is responsible for the woman's disability.

Neither Wyeth, their attorneys nor the Prices could be reached for comment. The Prices' attorney, Delmar Kuchaes, of Lakes of the Four Seasons, declined comment. Most Americans assume the highly infectious and paralyzing disease went the way of the iron lung, the nuclear fallout shelter in the basement or other harrowing relics of the 1950s. Polio was the most feared epidemic of that decade, infecting more than 21,200 in the peak year of 1952, according to Curtis Allen, a spokesman for the Centers for Disease Control and Prevention in Atlanta.

The disease enters through the mouth, travels through the stomach and into the blood stream, where it attacks the nervous system, often causing permanent paralysis. Jonas Salk pioneered the first vaccine, which reduced new infections by more than 60 percent. Another researcher, Albert Sabin, introduced an oral vaccine in the early 1960s that together with Salk's eradicated the disease in the United States in the late 1970s. It still occurs in some African and Asian countries.

Price was part of a tragic postscript. About 150 people were reported infected by vaccine-borne polio between 1980 and 1999. The Prices filed suit in Lake Circuit Court in 1993 against American Cyanamid Co., alleging the oral vaccine was administered to an unidentified infant with whom Cathy came into close contact during the summer of 1991. They alleged the vaccine was defective.

Dr. Marny Eulberg, of Post Polio Health International, said last week, "The oral vaccine was an attenuated live polio vaccine they had altered to make it non-infectious. But when it's in somebody's gut it can mutate and change. "The folks who got vaccine-associated polio, about half of them are children who had an immune deficiency that no one knew about. The other half were child-care providers who generally were not vaccinated, who came in contact with live virus the children excrete in their stool," Eulberg said. It is unclear from the record whether Cathy Price hadn't been vaccinated before or that her immune system was compromised, but the result was devastating.

Circuit court documents indicate Charles Price told a health-care investigator in the 1990s the disease changed everything in their lives. She had worked at a deli, a bakery and a discount store. Her husband works at Safety-Kleen of Dolton. She used to roller skate regularly, bowl a 126 average, play bingo, miniature golf, sing in her church choir, help in the nursery. They had no children but were thinking of adopting one.

She came home from the hospital several weeks after her diagnosis, unable to use her legs and with weakness in her upper body. Lawyers for Cyanamid filed papers in federal court last week stating the couple put their suit against Cyanamid on hold in 1993 to pursue compensation under the National Childhood Vaccine Injury Act of 1986. That law requires people hurt by vaccine mishaps to ask the federal government to pay medical bills and lost income before pursuing a lawsuit. State court documents indicate Cathy Price accepted federal compensation and is precluded from pursuing any suit, but her husband could continue to sue Cyanamid for damages he had suffered from the loss of a healthy wife.

Charles reactivated the Circuit Court suit and won a $5 million judgment in 2000 against the pharmaceutical company, which didn't appear in court to oppose the order. Cyanamid lawyers stated last week they were never notified of the reactivated suit until earlier this month, when they were ordered to pay up.

Bill Dolan can be reached at bdolan@nwitimes.com or (219) 662-5328.

A rare condition

Less than 1 percent of all polio infections result in paralysis. Many people recover completely and, in most, muscle function returns to some degree. Weakness or paralysis still present a year after onset is usually permanent.

Fighting the disease At one time poliovirus infection occurred throughout the world. Transmission of wild poliovirus ceased in the United States in 1979, or possibly earlier. A polio eradication program conducted by the Pan American Health Organization led to elimination of polio through the Western Hemisphere in 1991. The Global Polio Eradication Program has dramatically reduced poliovirus transmission throughout the world. Poliovirus transmission now occurs primarily in the Indian subcontinent, the Eastern Mediterranean and Africa.

Modern cases of polio

From 1980 through 1999, a total of 152 confirmed cases of paralytic poliomyelitis were reported, an average of eight cases per year. Six cases were acquired outside the United States and imported. The last imported case was reported in 1993. Two cases were classified as indeterminant (no poliovirus isolated from samples obtained from the patients, and these persons had no history of recent vaccination or direct contact with a vaccine recipient). The remaining 144 (95 percent) cases were vaccine-associated paralytic polio caused by live oral polio vaccine.

Vaccine-associated paralytic polio (VAPP) is a rare adverse reaction following live oral poliovirus vaccine. Inactivated poliovirus vaccine does not contain live virus, so it cannot cause VAPP. The mechanism of VAPP is believed to be a mutation, or reversion, of the vaccine virus to a more active form. Reversion is believed to occur in almost all vaccine recipients, but it only rarely results in paralytic disease. The paralysis that results is identical to that caused by wild virus, and may be permanent.

"But despite all the preparation for the launch of a new vaccine, at 5pm last night the government could not say how many payments had been made, what they totalled and how many claims were outstanding. "

Witnesses for Petitioners Are Often Tough to Find *Few medical experts are willing to testify in vaccine court that shots can cause harm.

By Myron Levin, Times Staff Writer

The vaccine court can be a hostile place not only for petitioners but for their expert witnesses too. Take the case of Dr. Derek Smith. A neurologist and assistant professor at Harvard Medical School, Smith had been retained to testify for people with transverse myelitis, a potentially paralyzing neurological disorder.

Smith said he was "highly confident" that the tetanus vaccine could trigger the ailment in certain vulnerable individuals. Officials with the Vaccine Injury Compensation Program strongly disagreed. Petitioners in vaccine court can have a tough time finding top experts, in part because many doctors are reluctant to say vaccines can cause harm. But Smith had no such qualms. "He was so smart," said Sylvia Chin-Caplan, a lawyer for dozens of victims of the neurological ailment. "I had somebody who had academic credentials, who did research and had a clinical practice," she said. "Those are the best people you can get."

Then Smith quit.

According to court papers and interviews, Smith decided to bail out after complaints were lodged with his superiors by three other experts with a long history of testifying for the government in vaccine court.

Smith had raised the ire of one of these men — Dr. Roland Martin, a prominent researcher at the National Institutes of Health. The two had gone head-to-head as opposing witnesses, and Martin claimed that Smith had mischaracterized some of his research. Early in 2002, Smith was informed by his supervisors, Dr. David Hafler at Harvard and Dr. Howard L. Weiner of Brigham and Women's Hospital in Boston, where Smith had his clinical practice, that people they respected told them Smith "was ruining his reputation by his testimony in the vaccine program," according to a document filed in vaccine court. Wary of antagonizing people who could affect his career, Smith decided to drop out after testifying in one last case, according to Chin- Caplan and other sources. Although there were no explicit threats, Chin-Caplan said Smith was told in so many words that he was jeopardizing his access to research funding.

His loss "was really heartbreaking," Chin-Caplan said. She also considered it a case of witness tampering.

Smith declined to be interviewed. None of the five other doctors — his supervisors and the three government witnesses — would comment. Nor would program officials discuss the propriety of their witnesses contacting Smith's bosses. They said in a written statement that they were "not privy to and cannot control professional interactions on the part of VICP medical experts."

It was not the first time a key witness for petitioners was lost to hard-nosed tactics. Another time, Justice Department lawyers persuaded an expert to switch sides, helping them defeat a string of claims. The cases involved children who suffered seizures and brain damage after diphtheria-pertussis-tetanus, or DPT, vaccinations. But the children also had a congenital condition — tuberous sclerosis, or TS — that could trigger seizures by itself. The issue was whether the shot or only TS was to blame.

Petitioners won a couple of these cases in the early 1990s, thanks to testimony by Dr. Manuel Gomez of the Mayo Clinic, described in court rulings as "the world's expert in TS."Facing at least two dozen similar claims, the government mounted an aggressive counterattack. It retained three experts who then published three medical journal articles that supported the government's stand, according to program records.

And without the knowledge of petitioners, government attorneys also contacted Gomez, briefed him on the work of their other experts and retained him as a defense expert. Gomez was "the guru of tuberous sclerosis," said Robert Moxley, a Wyoming lawyer for petitioners. His defection "was completely pivotal." Like Chin-Caplan, Moxley described the government's actions as witness tampering.

In September 1997, Special Master Laura Millman issued a lengthy ruling in the government's favor — basically finding that TS, not the vaccine, is usually responsible when TS infants suffer seizures. Gomez,Millman noted, had believed otherwise, "but in light of his more thorough education in the literature (courtesy of respondent) he has changed his mind."

Her ruling led to the defeat of most TS claims.

Contacted recently, Gomez said he had altered his opinion "mainly from accumulated evidence." Otherwise, he said, "I don't think I have much to tell you." Millman's ruling was affirmed in 2001 by the U.S. Court of Appeals for the federal circuit, which also found no proof of improper conduct in the government's hiring of Gomez.

Subject: Battled since 1988

£85,000 for parents of MMR victim By Neale Adams

Carol Buxton received Â£85,000 compensation after it was confirmed that the brain damage suffered by her daughter Hannah, who later died after a violent fit, was linked to the MMR jab.

Hannah endured up to 40 fits a day following her vaccination in 1988. She died three days before her third birthday.

Mrs Buxton and her husband Tony, a police officer, fought for compensation but were initially turned down by the Vaccine Damage Unit.

In 1992 the Buxtons, who also have three sons, appealed and four months later received a letter from the unit. It stated: "Hannah Buxton was disabled as a result of a vaccination to which the claim relates." It said the reaction to the jab had caused Hannah's development to deteriorate. The evidence was uncontested by the Government.

Travel consultant Mrs Buxton said: "The most important thing was someone confirmed what I had always suspected - the MMR jab had done so much damage to her brain that she became severely handicapped and started having fits."

A St. Louis jury awarded a teen $8.5 million late Thursday for injuries he said were linked to a polio vaccination 18 years ago. The lawsuit alleged that Cortez Strong, 18, contracted polio after he received an oral vaccine as an infant. Lawyers for Strong, who lives near Tower Grove Park in St. Louis, say he has limited use of his left arm and right hand.

Strong sued American Cyanamid Co., maker of the vaccine, and Dr. Georgia Santo-Jawaid, his former pediatrician in 1999. She formerly worked with a doctors’ group in the 3900 block of South Grand Boulevard, where Strong received the second dose of medicine when he was four months old.

Jurors gave Strong the full $8.5 million he asked for -- $1.5 million for past pain and suffering, $2 million for future missed earnings and $5 million for future pain. Strong, who currently works as a courtesy clerk at a Shop ‘n Save in Maplewood, turned down $50,000 from a vaccine compensation fund in order to sue, said one of his lawyers, Thomas Germeroth.

Doctors risk being sued by patients after ministers ordered the import of hundreds of thousands of unlicensed MMR vaccinations.

The Department of Health has bought in 400,000 doses of the vaccine from abroad to tackle a mumps epidemic. Because the vaccinations are unlicensed in Britain, GPs who administer them are exposed to legal action if a patient falls ill or dies as the result of the immunisation. The imported vaccines - Triplovax from Germany and MMR II from the United States - are identical to Britain's MMR II vaccine, which is supposed to be given to all infants in the country to protect against measles, mumps and rubella, but the imports do not have a specific product licence for the UK. Licences are granted by the Medicines Healthcare Products Regulatory Agency when drugs meet the approved standards.

The imported vaccines are being targeted at older children and teen-agers, who have been badly hit by the mumps epidemic. The move is likely to fuel criticism of the Government's apparent determination to press on with use of the triple vaccine, which has been linked by some to autism and bowel disease. It is given to children at around 14 months, and again at between three and five years.

A British Medical Association spokes--man said: "If a doctor prescribes an unlicensed drug and should there be a complication, then that doctor is individually liable. We want a guaranteed indemnity." A Department of Health spokesman said: "Unlicensed MMR was imported as an emergency measure due to extraordinary circumstances. Licensed products will always be procured as a preference." Andrew Lansley, the shadow health secretary, said: "I hope the issue of legal action will not arise but clearly under these circumstances the Department of Health should consider an NHS indemnity."

Dr Bradford, who practises from the Caen Medical Centre in Braunton, had challenged the finding that he had breached his duty of care.

On Tuesday, Lord Justice Waller, one of the three Court of Appeal judges, said it was a "tragic case" but said "no doctor could have foreseen" that the abscess meant Hamish was at a greater risk than other babies of contracting the vaccine strain of polio.

The judges also ruled Dr Bradford had not been negligent in advising the parents to go ahead with the vaccination, nor was he negligent in failing to inform them that the abscess was unusual and surgery might be necessary. Hamish Thompson was eight weeks old when he was vaccinated in December 1997.

Last November, High Court judge Mr Justice Wilkie said Dr Bradford was "unnecessarily dismissive" of Hamish's parents and failed to give them "the full picture" when they took their son to be vaccinated.

Ineffective immunisation

At the time, Hamish was suffering from a recurrent abscess on his bottom which was being treated by Dr Bradford. Hamish was left severely physically disabled by the disease - he cannot sit unassisted, needs a spinal jacket, has no grip in his left hand and cannot use his legs to crawl, stand or walk. Lord Justice Waller said the GP had not gone into the question of whether the immunisation should be postponed.

He said even if he had, it would not have been because of the baby's risk of contracting polio, but because of discomfort to Hamish following the immunisation and surgery or the risk of the vaccination failing. . http://news.bbc.co.uk/2/hi/uk_news/england/devon/4481794.stm http://www.cin.org/archives/cinhealth/199811/0060.html Vaccine injury compensation harder to get

A number of children receiving vaccines like DPT, MMR and Varivax are seriously injured immediately after receiving the vaccine. (Additionally, there is some evidence that there are some long term effects from the vaccines and that the attenuated viruses do not behave themselves but rather hide in lymphocyte B cells and other places to cause strange autoimmune responses including Crohn's disease.) For those children immediately injured, the government began a compensation program 10 years ago. Since the program began, there have been over 3200 claims, 60 percent of which have been turned down.

And lately, the government is making it even harder to claim compensation, an article on CNN stated. Because of this, the program is drawing more and more criticism. How many children are injured remains unknown. The medical field suggests that reactions are extremely rare however, I have personally heard about three adverse reactions to the DPT shots, one of which was reported in the newsletter of the National Epilepsy Foundation recently. Two other cases I heard about from people I work with who personally know the victims. That suggests to me that cases of reactions are more prevalent than some would like to admit.

This is only the immediate reactions and does not include long term reactions - things like the much higher rate of asthma in vaccinated children than in unvaccinated children are, as yet, not well studied or reported. More study needs to be done. Unfortunately those who are in the best position to study the long term side effects of vaccines and other like issues are also selling the vaccine so I don't think any studies will be done in the near future.

The Florida Times-Union

March 11, 2008

Vaccine award brings parents slight solace

By Paul Pinkham, The Times-Union

For Chris and Sarah Hoiberg, the multimillion-dollar award they and their daughter received from a national vaccine injury fund is a bittersweet victory. -------------------------------------------------- --------------------------------------------------

The Jacksonville couple would much rather have 4-year-old Caitlyn back the way she was before a common cocktail of childhood immunizations left her brain-damaged and prone to seizures. Back when she was a normally developing child with a growing vocabulary and zero health problems. Caitlyn hasn't spoken a word since receiving the shot two years ago and suffering a seizure the following morning. Her left arm is partially paralyzed and she still walks like a toddler. The family spent a nightmarish week in a pediatric intensive care unit, as Caitlyn had multiple seizures and slipped in and out of consciousness. "I told Chris this might be it," Sarah Hoiberg said. "I thought she was dying." In September, a judge on the U.S. Vaccine Court in Washington - where all vaccine injury cases are heard - made a rare finding that Caitlyn's injuries were caused by the DTaP vaccine, which combines immunizations for diphtheria, tetanus and pertussis (whooping cough). DTaP is a common child vaccine, regularly administered by pediatricians. The U.S. Justice Department then settled the case for about $337,000 plus two annuities in Caitlyn's name that are worth millions of dollars. The exact amount depends upon her life span and future needs. The money will come from a vaccine injury compensation program funded by a 75- cent surcharge on all vaccinations in the country. "Everybody agreed at the end of the day that the vaccine caused her injury," said Alan Pickert, the Hoibergs' attorney, who represents 56 other Jacksonville-area families in Vaccine Court. Bob Harmon, director of the Duval County Health Department, said the vaccine compensation program was set up for infrequent cases like Caitlyn's. But those cases are so rare, he said, "parents should not be concerned." "On the balance, the benefits of the vaccines greatly outweigh the risks. There have been huge developments in child health because of the vaccines," Harmon said. "There are occasional rare complications with any medical procedure." Those type of explanations anger the Hoibergs, who have not had either of their daughters vaccinated since Caitlyn got sick. "That's something easy to say when it's not your child," Chris Hoiberg said. Sarah Hoiberg never imagined how a routine trip to the doctor would change her family's life. She had taken her older daughter, Laura, for the same shots and studied them then. There were no complications. She remembers asking her pediatrician about literature that made note of possible seizures, and he told her he had never had a child react that way in 30 years of practicing medicine. So when Caitlyn turned 19 months and it was her turn, her mother, like most parents, thought of it as a childhood rite of passage. "We're law-abiding citizens. If they say to vaccinate, we vaccinate," she said. But by the next morning, Sarah Hoiberg knew something was terribly wrong. She remembers checking on Caitlyn and finding her staring blankly, her left side rigid. She called 911, and Caitlyn was taken to the hospital with encephalopathy, a brain disease. Sarah said she immediately suspected the vaccinations, but doctors tested her daughter for "everything from mad cow disease to cat scratch fever." "I've never seen so many doctors so perplexed," Chris Hoiberg said. Eventually, a neurologist at Nemours Children's Clinic identified the DTaP vaccine as the cause. His testimony made the case easier to prove and quicker to resolve than most vaccine injury claims, Pickert said. He initially cautioned the Hoibergs that the case could take eight years to resolve. "There are multiple people out there who have vaccine-injured children," Pickert said. "They don't know they're vaccine-injured. They haven't connected the dots." Today, Caitlyn has made strides, but her parents have no idea what the future holds. The vaccine award has allowed them to pay for therapy and will ensure she is cared for the rest of her life. But at best, her mother said, she'll probably always have to have an attendant with her. Her parents urged others to educate themselves about the risks of childhood vaccines. "You can't let fear run your life," Sarah Hoiberg said. "But it's not something to be taken lightly." paul.pinkham@..., (904) 359-4107

Submitted by ElaineAMoore on Mar 22nd, 2009http://www.emaxhealth.com/1035/39/30034/polio-vaccine-award-opens-doors-researchers.html Posted under: The problem with treated live vaccines has always been that live viral particles can occasionally cause infection in the vaccinated person as well as people they’re exposed to. A prime example is the chickenpox vaccine, which is a well known cause of shingles in older adults exposed to vaccinated children. On Friday, jurors found that active polio vaccine was the cause 30 years ago when Staten Island resident Dominic Tenuto contracted polio after changing the diaper of his recently vaccinated 5-month old daughter. Now 61, Tenuto said that his bout with polio caused partial paralysis and led to his losing his job on Wall Street. In the March 20, 2009 verdict, the jury in the polio vaccine injury trial awarded Tenuto damages in the amount of $22.5 million to be paid by Lederle, the manufacturer of the vaccine. This was the highest amount for damages ever awarded by a Staten Island Jury. The drug company plans to appeal. This ruling, which clearly links an active viral vaccine to an active viral infection is important in more ways than the obvious. Earlier this year, a panel found that the measles, mumps an rubella vaccine bore no relationship to autism, despite the finding of live viral particles in vaccinated children. Current lawsuits are pending in the cases of several deaths attributed to the Gardasil vaccine used to prevent human papilloma virus (HPV) cancer, a known cause of cervical cancer. The oral polio vaccine has a long history of controversy. The oral polio vaccine developed by Albert Sabin was first licensed in 1962. The vaccine was produced by culturing the virus in monkey kidney tissue. The monkeys used are known to harbor a number of cancer-causing viruses. One virus in particular, simian virus 40 (SV 40) is known to cause a variety of cancers, particularly lung, bone, and brain tumors and is thought to be responsible for the vast increase in leukemia seen in the last 20 years. This lawsuit opens doors, hinting of compensation for others directly affected by the oral polio vaccine and encouraging the studies of researchers who have long suspected the vaccine to be responsible for numerous health problems. Source: Elaine A Moore